Product Compliance
Test/Filing/Registration
The classification and definition results of medical devices from July 2020 to December 2021 are 1077, among which:
. 155 products are recommended to be managed according to class iii medical devices;
. 505 products are recommended to be managed according to class ⅱ medical devices;
. 143 products are suggested to be managed according to class I medical devices;
. 51 products that are not recommended to be managed separately as medical devices;
. 197 products are not recommended to be managed as medical devices;
. 20 products is suggested to define with management attributes according to the determination procedure of medicinal device combination products;
. 6 products are suggested depending on the specific situation.
The classification and definition result of relevant products is based on the information provided by the applicant, which does not represent the approval of the safety and effectiveness of the product, but only serves as a reference for the registration and filing of medical device products. The product description and intended use in the results are used to determine the management attributes and categories of the products and do not represent a complete description of the relevant product registration or filing content. "00" is used to represent the "classification code" that does not correspond to the first-class product category temporarily in the Classification Catalogue of Medical Devices, for example, the classification code of "X-ray bone age testing equipment" is 06-00.
1. 155 products are recommended to be managed according to class iii medical devices;
1. Absorbable tissue sealing film: it is composed of poly (lactide ethyl lactide) copolymer (PLGA), n-vinyl-pyrrolidone, acrylic acid, n-acrylic hydroxyl succimide ester copolymer, with a four-layer structure. The first layer and the third layer are made of polyvinyl lactide copolymer (PLGA). The second and fourth layers are made of copolymers of N- vinyl - pyrrolidone, acrylic acid and N- acrylic hydroxyl succimide ester. Sterile products for single use. Claims that the fourth layer can be directly in contact with tissue, n-vinyl-pyrrolidone, acrylic acid to provide initial viscosity, so that the product adhere to tissue surface; The first, second and third layers act as barriers and seals to prevent adhesion with nearby tissues and air leakage during wound healing. Used for sealing or strengthening air leakage in thoracic surgery, low pressure leakage or slow bleeding of soft tissue or fluid leakage in surgery. Classification code: 02-13.
2. Medical temperature-sensitive HYDROXYbutyl polysaccharide joint cavity injection: composed of hydroxybutyl chitosan, mannitol (osmotic pressure regulator), hydrochloric acid (pH regulator) and water for injection. Sterile products for single use. At a lower temperature, it is liquid mucus with low viscosity. When the joint cavity is narrow and bone wear causes pain, it is injected into the joint cavity. As the temperature rises to body temperature, it gradually changes into semi-fluid gel with high viscosity, alleviating symptoms through the lubrication effect of gel and alleviating pain caused by joint friction. As an intra-articular lubricant, used to lubricate joints in traumatic or degenerative osteoarthritis. Classification code: 02-15.
3. Suture system for disposable endoscope: it is composed of suture system (including handle, conveying system, polyethylene suture, threaded nail, bracket, wherein the threaded nail is put through the suture line) and pusher (handle, conveying catheter, lock). Made of polyethylene, stainless steel, polyether ether ketone material. Sterile products for single use. It is used under endoscope to suture digestive tract soft tissue in minimally invasive gastroenterological surgery. When used, screw screw is fixed on the edge of mucosal defect first, and after all screw screw is placed, the thread is closed and the screw screw is tightened to achieve the purpose of closing the soft tissue defect. Threads, locks, and sutures were left in vivo for more than 30 days. Classification code: 02-13.
4. Arterial thrombus balloon catheter: it is composed of main catheter with balloon at the end, thrombus intubation, ruhl concave connector, metal sleeve, probe, large hole convex ruhl interface lock plug, extension tube, spring and distal protective cap. Made of nylon, PVC, medical stainless steel and natural latex. Sterile products for single use. To use it, a constricted balloon is inserted into the blood vessel through an arteriotomy. The balloon is moved above the clot and filled so that the balloon comes into contact with the blood vessel wall. The balloon is then withdrawn, and the thrombus beneath the balloon moves under the traction of the balloon and out of the body through the arterial incision. It is used to remove new soft thrombus in the peripheral arterial system. Classification code: 03-13.
5. Disposable temperature measuring central venous catheter kit: it consists of temperature measuring central venous catheter (non-hydrating catheter), puncture needle or indwelling needle, guide wire, dilating tube, syringe (with needle), scalpel, heparin cap, butterfly clip, disinfection brush, suture needle, application, medium single, small single, hole towel, large hole towel and gauze. Temperature measuring central venous catheter is composed of soft tip, catheter body, connecting joint, extension tube, seat, locking clip, sensor lead wire, sensor plug and temperature sensor. The puncture needle consists of a needle holder and a needle tube. Guide wire is composed of core wire and winding wire. The expansion pipe consists of an expansion pipe body and a joint. Butterfly clip consists of coat and lining. Temperature measurement of central venous catheter, soft tip catheter tube body and connector, extension tube, sensor plugs, sensors, lead wire coat with polyurethane (PU) material, a thermistor temperature sensor, the sensor plug internal metal parts and sensor lead wire transmission cable with copper, use of polycarbonate (PC) material, The locking clamp is made of styrene-butadiene-acrylonitrile copolymer (ABS). The needle tube is made of stainless steel and the needle holder is made of PC. The guide wire is made of Nitinol alloy, and the winding wire is made of stainless steel. The expansion tube is made of polypropylene (PP) material. The coat of butterfly clip is made of ABS material, and the lining is made of vinyl chloride (PVC) material. Sterile products for single use. In central venipuncture catheterization and deep venipuncture catheterization, it is inserted into the central venous system for infusion of liquid medicine or blood sample extraction and/or pressure measurement, and can be used together with a host with temperature monitoring function to measure the central venous blood temperature of patients. Classification code: 03-13.
6. Peripheral blood infusion catheter set: it consists of infusion catheter unit and electric handle. The infusion catheter unit consists of a catheter with an opaque ray mark and a scattered guide wire that can rotate 360°. The electric handle unit consists of a speed selector, a handle power supply, a syringe and a locking support structure. Made of polymer material. It is a sterile product for single use. When used, the infusion catheter was inserted percutaneous into the peripheral blood vessel through the micropuncture sheath. Under the angiography technique, the guiding catheter and the dispersive guide wire reached the treatment site along the blood vessel. Then select the drug to be injected and the injection speed through the electric handle in vitro. Under the control of the doctor, the liquid is injected into the infusion catheter through the one-way valve of the infusion catheter unit and the liquid inlet of the dispersed guide wire, and continues to be injected into the peripheral blood vessel along the opening of the distal end of the infusion catheter. For infusion of drugs into the peripheral vascular system. Classification code: 03-13.
7. Vertebroplasty instrument kit: it is composed of shaped balloon, expander, puncture needle, drill, guide needle and measuring rod. It is made of polycarbonate (PC), glass fiber, thermoplastic polyurethane and stainless steel. Sterile products for single use. In percutaneous kyphoplasty/percutaneous vertebroplasty, the deformed balloon is inserted into the vertebra, the deformed balloon is opened to compress the cancellous bone, and the remaining cavity after the retracting of the deformed balloon forms a working channel filled with bone cement to restore the anatomical structure of the vertebra. Classification code: 04-17.
8. Acellular dermal matrix: it is prepared from pig skin by virus inactivation, decellularization and galactose antigen removal. Its main component is collagen. Contains no living cells. It claims that the product can provide scaffold for human somatic cell reproduction and regeneration, and is used for covering treatment of burn wounds, trauma wounds, granulation wounds and other wounds. Classification code: 13-10.
9. Biological heart valve patch: biological valve leaf material made from the pericardium of healthy cattle. Sterile products for single use. It is used to replace the damaged, diseased and malformed heart valve by surgical implantation to repair the valve opening and closing function. Classification code: 13-07.
10. Stainless steel wire for bone joint: it consists of stainless steel wire and medical stainless steel suture needle. It is used for non-soft tissue suturing or binding fixation in operation, such as sternum closure. They don't take it out after they're implanted. It is used for non-soft tissue suturing or binding fixation in operation, such as sternum closure. They don't take it out after they're implanted. Classification code: 13-01.
11. Recombinant type iii collagen bladder repair agent: composed of recombinant type III collagen and disodium hydrogen phosphate. Sterile products for single use. It is used to temporarily cover bladder epithelium to replace the barrier function of glycosaminoglycan layer and block urinary stimulation to bladder epithelium. Classification code: 13-11.
12.
Prostatic urethral stent system: it is composed of stent, conveying system, expansion sheath, guide wire, three-way valve and infusion tube. Made of nickel-titanium alloy material and polymer material. Sterile products for single use. It is used to treat strictures caused by hyperplasia of the prostate or urethra, and stents are implanted to drain urine. When used, the delivery system loaded with the stent is inserted into the target site (penile urethra, bulbar urethra, prostatic urethra or bladder neck) through the external urethra, and then hot water with temperature above 55℃ is injected through the delivery system to make the stent head expand automatically. The stent tip is expanded and released from the delivery system and supported at the target site (penile urethra, bulbar urethra, prostatic urethra, or bladder neck). Stents are implanted long term. Classification code: 13-09.
13. Medical temperature-sensitive biological glue: composed of hydroxybutyl chitosan, mannitol (osmotic pressure regulator), hydrochloric acid (pH regulator) and water for injection. Sterile products for single use. Claims for knee, hip, ankle, shoulder and other parts of the articular cartilage injury after filling the hole, at low temperature for liquid flow state, after the injection of the human body temperature can gelation in the hole, into non-current stents solid, remain in situ, stop the ooze blood seeping, to ensure their own blood for cartilage repair. Classification code: 13-05.
fourteen containN-butyl-Cyanoacrylate Ethyl iodized oil Liquid embolic agent set of tantalum powder fromN-butyl-Cyanoacrylate N-BCA Ethyl iodized oil Tantalum powder consists of three parts.It is a disposable sterile product.When used,After mixing the three components in vitro, they were delivered to the target site of the patient through the femoral artery.After the mixture comes into contact with body fluid or tissue,N-BCAPolymerize to form solid embolism,It is used to block or reduce blood flow to specific peripheral and neurovascular sites requiring embolization.Claim that ethyl iodide is used to changeN-BCAPolymerization rate of,Tantalum powder can makeN-BCAPolymers have non transmission linearity.Classification code 13-06.
fifteen Absorbable lifting wire for shaping It is composed of medical guiding needle and absorbable lifting wire.The medical guide needle is made of medical stainless steel,The absorbable lifting wire is made of poly (p-dioxane cyclohexanone) material,The thread body is spiny.It is a disposable sterile product.It is used in plastic and reconstructive surgery of patients,The absorbable lifting wire is implanted into the soft tissue of the body surface through a medical guide needle,Lift, reposition and fix the loose subcutaneous tissue,Correction of loose and sagging soft tissue,To help the patient improve the relaxation of skin or soft tissue Ptosis symptoms.Classification code 13-09.
sixteen Modified sodium hyaluronate gel for injection: it consists of a prefilled syringe, stainless steel injection needle and gel particle suspension encapsulated in the syringe. The gel particle suspension consists of partially modified sodium hyaluronate, sodium chloride, disodium hydrogen phosphate, disodium hydrogen phosphate and water for injection. Sterile products for single use. For labia majora injection filling to correct atrophy. Classification code: 13-09.
seventeen Adjustable throat implant: it is composed of titanium shell (including integrated port chamber and silicone port film), sliding suture, fixing screw, screw fixing plate and expandable silicone pad (silicone balloon). Made of medical silicone, titanium and polyester materials. Sterile products for single use. Type I thyroplasty, long-term implantation of the thyroid cartilage plate in patients with unilateral vocal cord paralysis (UVFP)/glottic insufficiency. Claimed by silica gel balloon injection/remove physiological saline, adjust the size of silica gel balloon, squeeze the vocal cord, vocal cords in the middle of the paragraph and ligament in oppression to the throat center line (or to the side of the vocal cords), and resist arytenoid vocal cords, thereby promoting arytenoid rotation, to improve unilateral vocal cord paralysis (UVFP) of patients with closed/glottis voice quality. Classification code: 13-08.
eighteen Blood flow guiding mesh stent system: it consists of braided implants and delivery system, including guiding sheath components. The conveying system consists of head end coil, distal marker, proximal buffer, conveying wire, proximal sea wave tube, protective sheath, reentry sheath gasket and reentry sheath marker. The woven implant is a mesh cylinder. The surface of the implant was modified by phosphocholine (PC) polymer by means of chemical bonding with the alloy surface to form a coating. Braided implants are made of platinum tungsten alloy, thin wire diameter 35NLT alloy or platinum tungsten alloy, thin wire diameter 35NLT alloy and thick wire diameter 35NLT alloy. Sterile products for single use. When used, braided implants are implanted into the cerebrovascular system through the blood vessels (such as the femoral artery) through the delivery system, and the blood flow into the arterial tumor is restricted by the occupying blockage of the braided implants, so that the blood flow in the aneurysm is stagnant until the tumor gradually shrinks. Endovascular treatment of large or large wide neck aneurysms (IAs) from the rock segment of the internal carotid artery to the proximal opening of the superior pituitary artery in adults (22 and older). It is also used for intracavascular treatment of small and medium-sized wide-necked (cervical width ≥4mm or body to neck ratio < 2) and cystic or fusiform aneurysms with parent artery diameter ≥2.0mm and ≤5.0mm in adults (22 years and older). It is claimed that there are phosphocholine groups on the surface coating, and the outer membrane surface of red blood cells is also covered by phosphate groups. By physiologically imitating the human red blood cell membrane, it can be disguised as non-foreign bodies, so as to avoid the activation of the coagulation system and reduce the thrombosis of vascular pathways. Classification code: 13-07.
nineteen Gellan gel phase change gel for intrauterine use: it consists of a prefilled syringe, an extension tube and gel presealed in the syringe. The gel is composed of low acetyl gellan (a linear polysaccharide consisting of glucose, glucuronic acid and rhamnose as repeating structural units), hydroxypropyl methylcellulose and water. Sterile products for single use. Injected into the uterine cavity and attached to the endometrium, the low acetyl knot gellan meets the metal cation in the uterine cavity fluid and turns into a solid gel (the manufacturer claims that there is no chemical reaction in this process), which can protect the wound surface and physical barrier, and reduce the adhesion of the uterine cavity tissue. It is used to prevent the readhesion of tissues after the release of moderate and severe intrauterine adhesions, or to help reduce the occurrence of intrauterine adhesions after operation. Classification code: 14-08.
twenty Soluble sodium hyaluronate microcrystalline roller: it is composed of a handle, an inner core of the roller, a medical pressure-sensitive adhesive and soluble sodium hyaluronate microcrystalline. Soluble sodium hyaluronate microcrystals are made of sodium hyaluronate, water, glycerin, trehalose and sodium alginate. Sterile products for single use. On the one hand, it claims to improve the transdermal absorption efficiency of drugs applied to the skin surface through microporous channels formed by soluble sodium hyaluronate microcrystals; Used to promote transdermal absorption of drugs. Use on whole skin only. On the other hand, it claims that soluble sodium hyaluronate microcrystals made of sodium hyaluronate can be dissolved and absorbed in the body, used for topical moisturizing, and to prevent lingering damage to the skin caused by broken microcrystals. Classification code: 14-01.
twenty-one Silver-containing dressing: composed of sodium alginate - silver metal ion complex and polyester non-woven fabric. It is used for wound nursing, such as infected wounds, lower limb ulcers, diabetic foot ulcers, pressure ulcers, burns, surgical incisions, etc. At the same time, the antibacterial mechanism of silver plays an auxiliary role in reducing wound infection. Classification code: 14-10.
twenty-two Disposable sterile injection needles: divided into single needle and multiple needle. Single needle product is composed of needle holder, needle tube and protective sleeve, multi-needle product is composed of needle holder, needle tube, needle table and protective sleeve. Needle tube is made of stainless steel, needle stand, needle holder and protective sleeve are made of polymer material. Sterile products for single use. It can be used with syringe for intradermal, subcutaneous and muscular injection. Classification code: 14-01.
twenty-three Medical multi-head microneedle: it is composed of multiple hollow microneedles, needle holder and sheath. Microneedles are made of medical stainless steel, with holes in the head. The maximum exposed length is no more than 2mm, and the number of microneedles is 5, 9 or 12. Sterile products for single use. No drugs. It should be used with syringes or injection instruments. It is used to inject human epidermal growth factor or sodium hyaluronate gel directly into the epidermis by penetrating the cuticle of the skin. Classification code 14-01.
twenty-four Disposable sterile medical microneedle: it consists of needle cap and microneedle. The microneedle consists of a needle holder and a silicon needle body. Disposable sterile products. It can be connected with a prefilled container or syringe to inject drugs into the skin through the cuticle. Classification code: 14-01.
twenty-five Soluble sodium hyaluronate microcrystalline drug delivery kit (without drug) : it is composed of soluble sodium hyaluronate microcrystalline, fixed tape and hydrogel layer. Sodium hyaluronate microcrystal is made of sodium hyaluronate and water. Fixed tape is made of high permeability non-woven fabric; The hydrogel layer is made of non-woven fabric, polypropylene resin, medical polyvinyl alcohol, purified water and glycerin. Sterile products for single use. When using, apply topical ointment on the affected area, paste the sodium hyaluronate microcrystal and fix it around it with medical adhesive tape, then flatly paste the hydrogel on the sodium hyaluronate microcrystal, press the finger for more than 10 times until the microcrystal penetrates the skin cuticle to help deliver the drug to the dermis. On the one hand, it is claimed that the microporous channels formed by soluble sodium hyaluronate microcrystals on the skin surface can improve the transdermal absorption efficiency of drugs applied on the skin surface. Used to promote transdermal absorption of drugs. Use on whole skin only. It can assist specific dermatitis drug administration. On the other hand, soluble sodium hyaluronate microcrystals made of sodium hyaluronate can be dissolved and absorbed in the body. The aqueous gel in the product can promote the dissolution of sodium hyaluronate microcrystals and repair the percutaneous water loss barrier caused by inflammatory skin diseases through the moisturizing effect of sodium hyaluronate. Classification code: 14-01.
twenty-six Collagen dressing: it is composed of collagen solution, methyl paraben, propyl paraben and nonwovens. For skin allergy, laser, photon postoperative wound repair. Classification code: 14-10.
twenty-seven Polyvinyl alcohol sponge drainage tube: it is composed of polyvinyl alcohol sponge, diversion tube and traction wire, and the polyvinyl alcohol sponge is composed of polyvinyl alcohol, bioactive glass and glycerol. Sterile products for single use. It is used for packing, hemostasis and imbibition of the postoperative cavity sites (anorectal, nasal and vaginal), maintaining the postoperative structure and morphology of the affected area, and draining the wound surface through the diversion tube. It can be used for chronic wounds. Classification code: 14-06.
twenty-eight Polyvinyl alcohol sponge dressing: it is composed of polyvinyl alcohol sponge, diversion tube (optional) and traction wire (optional). The polyvinyl alcohol sponge is composed of polyvinyl alcohol, bioactive glass and glycerin. Sterile products for single use. It is used to stop bleeding by packing and compression of cavity (such as nasal cavity and anorectal). It can be used for chronic wounds. Classification code: 14-06.
twenty-nine Hydroxybutyl chitosan wound repair material: hydroxybutyl chitosan, glycerin and water for injection. Sterile products for single use. On the one hand, the product keeps the wet environment of the wound, isolates the wound from the external environment, and promotes the healing of the wound. On the other hand, the porous structure of the product provides a three-dimensional scaffold structure for cell growth, enabling cells to grow and migrate freely in all directions. Used for the repair of burns and scald wounds (shallow ⅱ °, deep ⅱ °, ⅲ ° burns and scald) and incision wounds. Classification code: 14-10.
thirty Medical epidermal injection needle: it is composed of a needle cap, a needle holder and a needle body, with a through hole in the needle body and a length of 0.5mm-0.6mm. Sterile products for single use. It should be connected with a syringe pre-filled with cosmetic products or skin-trial substances for intradermal injection of cosmetic products or skin-trial substances. Classification code: 14-01.
thirty-one Disposable endoscopic needle: it consists of needle tube, outer tube, inner tube, handle and push handle. Sterile products for single use. It needs to be used together with digestive tract endoscope. When in use, it enters the human body through the endoscope instrument socket and controls the expansion and contraction of the injection needle through the handle. The handle end is connected with the syringe with the Ruhr interface to inject the digestive tract submucosa. After the injection is complete, the needle is withdrawn into the outer tube and slowly exits the endoscope forceps canal. It is used for submucosal injection of digestive tract. Classification code: 14-01.
thirty-two Wound su rface application containing type ⅰ collagen: it is composed of glue-coated non-woven cloth, absorption pad and isolation paper. The absorbent pad is made of type ⅰ collagen, which is spongy and porous. Isolation paper is paper (film) coated with silicone oil anti-stick agent. Sterile products for single use. It is used for the nursing of non-chronic wounds and provides a microenvironment for wound healing. It can also be used for nursing the puncture site of puncture instruments (such as catheters) and fixing puncture instruments. Classification code: 14-10.
thirty -three Pump type central venous catheter irrigator: it consists of catheter irrigator and pump body. The catheter washer is composed of coat, core rod, piston, cone head cap and 0.9% sodium chloride injection. The pump body is composed of a liquid feeding device, a liquid feeding device cap, an elastic liquid storage device (composed of a liquid storage capsule, a silica gel ring, a slide rod and a slide rod sleeve), a liquid filter shell, a liquid filter membrane, a flow limiting pipe, a pipeline, an outer cone joint, a joint cap and a pump shell. Sterile products. When used with catheter syringe pump body joint connection, will be prefi lled catheter syringe injection of 0.9% sodium chloride injection pump body of the liquid inside the device, after waiting for the liquid flow pump body outer taper joint, outer taper joint and pump body in patients with central venous catheter or venous indwelling needle in the body of the inner cone joint connection, Rinse the end of the central venous catheter or venous indwelling needle. Classification code: 14-16.
thirty -four Percutaneous gastrostomy set (including injection needle) : divided into TYPE K and type L. Type K consists of stoma tube, fixing ring, clamp, syringe, injection needle, puncture assembly, scalpel, guide wire, Y-type feeding joint, E-type feeding joint, gauze block and hole towel. L type is composed of stoma tube, fixing ring, clamp, syringe, injection needle, puncture component, scalpel, guide wire, Y type feeding joint, E type feeding joint, gauze block, hole towel, hemostatic forceps, surgical scissors and snare device. Made of silica gel, acrylonitrile/butadiene/styrene copolymer, 06Cr19Ni10, polypropylene, polycarbonate, fluorinated ethylene propylene copolymer, polyamide, cotton, ptfe material. Sterile products for single use. Through percutaneous puncture technique, it is used in conjunction with soft endoscopy to form feeding channels in the stomach for enteral nutrition. Injection needle is used for subcutaneous injection of anesthetics at stoma site. Classification code: 14-01.
thirty -five absorbable anti adhesion spray glue: by polymer suite (including powder, powder B, attract with double syringes, attract with Y pipe and attract with Y adapter), spray suite (including glass bottle connector, spray and double injector nozzle), dissolved water and air pressure regulator. Powder A is composed of n-hydroxysuccinimide carboxymethyldextrin and trehalose hydrate. Powder B is composed of sodium carbonate and sodium bicarbonate. The dissolved water is water for injection. When used in the powder and the powder B after dissolved into water to form A solution and B solution, using glass bottle connector will solution A and solution B, suction from the bottle into the spray with double syringes, connecting nozzle, out of the spray medium voltage double injector of two kinds of solution through the nozzle in the compressed air under the action of mixing, in the form of A mist, Attached around the injury site, A solution and B solution are cross-linked and esterified to form A cross-linked carboxymethyl dextrin-N-hydroxysuccinimide gel, which acts as A temporary physical barrier to prevent the fibrin deposition of the damaged mesoderm and avoid forming A bridge to connect with the tissue surface on the opposite side, so as to play an anti-adhesion effect. After that, the gel breaks down at the attachment site and is absorbed into the body, which is eventually metabolized and excreted out of the body. It is used for the peritoneal injury sites (abdominal wall, abdominal organs, uterus, uterus accessories, etc.) under the abdominal incision of patients undergoing abdominal or pelvic surgery to reduce the frequency, scope and degree of postoperative adhesion. Classification code: 14-08.
thirty -six Single-use lubricated bacteriostatic catheters are available in single, double and three-chamber models. The single-cavity catheter is composed of a drainage conical interface and a tube body. The double-cavity catheter is composed of a one-way valve, a filling cavity, a tube body, a balloon and a discharge conical interface. Some specifications are provided with guide wires. The three-cavity catheter consists of a plug, a flushing cavity, a one-way valve, a filling cavity and a conical discharge interface, a tube body and a balloon. The catheter is made of silicone rubber material and the guide wire is made of nylon. Catheter play with high hydrophilic cation modified polyvinyl pyrrolidone (PVP) copolymer coating, claimed that PVP molecules can be modified to a certain extent, prevent bacterial adhesion on surface of the pipe body, even if there are bacteria in the product surface, a small amount of cation can penetrate the bacterial cell membranes, inhibiting bacterial growth and colony formation and inhibition of bacterial adhesion and biofilm formation. It is used to export urine from the patient's bladder through the urethra and into the urine collection container. Classification code: 14-05.
thirty -seven Disposable lubricated bacteriostatic latex catheter: it consists of a tube body (with joint), a one-way valve, a balloon, a discharge hole, a catheter plug (optional), and an inner core (optional). Made of latex material. Sterile products for single use. The tube body is coated with cationic modified PVP copolymer lubricating antibacterial coating. It is used to export urine from the patient's bladder through the urethra and into the urine collection container. Classification code: 14-05.
thirty -eight Disposable lubricated bacteriostatic silicone catheter: it is composed of tube body (with joint), one-way valve, balloon, discharge hole, catheter plug (optional) and inserted inner core (optional). Made of silicone rubber material. Sterile products for single use. The tube body is coated with cationic modified PVP copolymer lubricating antibacterial coating. It is used to export urine from the patient's bladder through the urethra and into the urine collection container. Classification code: 14-05.
thirty -nine Foam dressing: divided into type ⅰ, type ⅱ and type ⅲ. Type ⅰ is self-adhesive, which is composed of matrix layer, hydrocolloid layer, polyurethane foam layer and isolation layer. Type ⅱ is non-self-adhesive, which is composed of matrix layer and polyurethane foam layer. Type ⅲ is non-self-adhesive type, composed of polyurethane foam layer. The matrix layer is made of polyurethane composite film sprayed with medical pressure sensitive adhesive. The hydrocolloid layer is made of medical polymer material sodium carboxymethyl cellulose (CMC-2NA), medical hot melt adhesive, polyisobutene and paraffin oil. Polyurethane foam layer is made of polyurethane and foaming agent by high pressure foaming; The isolation paper is grathine paper. Sterile products for single use. It can absorb the wound exudate and provide a moist environment for the wound. Used for covering and nursing surgical incision, abrasions, wounds, burns, donor area and other wounds. Classification code: 14-10.
forty Disposable lacrimal drainage tube set: consisting of lacrimal drainage tube (some models include single or double non-absorbable surgical sutures), lacrimal duct probe or lacrimal sac retractor and irrigating needle. The lacrimal duct drainage tube is made of silicone rubber material. The lacrimal duct probe, lacrimal sac retracer and rinsing needle are made of stainless steel. Sterile products for single use. Used for support, drainage and flushing after treatment of lacrimal canaliculi stricture, obstruction, rupture and dacryocystitis. The single/double non-absorbent surgical sutures are used to pull the drainage tube into position. Classification code: 16-07.
forty-one Contact lens lubricant: sodium chloride, hydroxyethyl cellulose, boric acid, borax, edTA disodium, polysorbate -80, purified water. Sterile products. Used to moisturize contact lenses and lubricate when wearing contact lenses. Classification code: 16-06.
forty-two Contact lens lubricant: composed of polyvinyl alcohol, sodium chloride, disodium edTA, potassium dihydrogen phosphate, anhydrous disodium hydrogen phosphate, sodium chondroitin sulfate, 20% solution of polyhexylguanidine (PHMB), sodium hydroxide and purified water. Sterile products. Used to moisturize contact lenses and lubricate when wearing contact lenses. Classification code: 16-06.
forty-ghree Contact lens lubricant: polyvinyl alcohol, hydroxypropyl methyl cellulose, taurine, sodium chloride, ethylenediamine tetraacetic acid disodium, disodium hydrogen phosphate, sodium dihydrogen phosphate, polyhexylbiguidine (PHMB) 20% solution, sodium hyaluronate, D-mannitol, purified water. Sterile products. Used to moisturize contact lenses and lubricate when wearing contact lenses. Classification code: 16-06.
forty-four Contact lens lubricant: composed of polyvinyl alcohol, hydroxypropyl methyl cellulose, taurine, sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate, disodium ethylenediamine tetraacetate, 20% solution of polyhexylguanidine (PHMB), sodium hyaluronate, D-mannitol, vitamin B12 and purified water. Sterile products. Used to moisturize contact lenses and lubricate when wearing contact lenses. Classification code: 16-06.
forty-five Silicone tube with line for the correction of ptosis can be implanted: it consists of a plastic metal probe, a silicone tube, a silicone sleeve and a connecting line. Both ends of the silicone tube are connected with a plastic metal probe through a connecting wire. Sterile products for single use. It is used for patients with ptosis correction surgery who need frontalis suspension. After implantation of upper eyelid and upper edge of eyebrow, the blepharon can be connected with frontalis muscle, and the kinetic energy of frontalis muscle contraction can be used to lift the upper eyelid, so as to restore the normal visual function of eyes of patients with ptosis. Classification code: 16-07.
forty-six Corneal preservation solution: sodium chondroitin sulfate for injection, dextran, alkali powder, sodium bicarbonate, genamicin sulfate, streptomycin sulfate, non-essential amino acid solution, sodium pyruvate solution, levoglutamide, 2-mercaptoethanol, sodium hydroxide. Sterile products. Storage of donor corneas in an in vitro cold storage (2-8°C) environment for up to 14 days. Classification code: 16-07.
forty-seven Eye laser therapy instrument: it is composed of host (including motherboard, optical probe and shell), adapter and eye laser therapy instrument software. There are three working modes, which are color light (multi-spectral LED light), laser one (multi-spectral LED light + acupoint laser), laser two (multi-spectral LED light + acupoint laser + eyeball laser), multi-spectral LED light is red, green and yellow three-color LED light, laser wavelength is 650nm±20nm, laser power is 2mW±25%, The laser spot diameter is 10mm±2mm. It claims that the macular area of the eye has a very high absorption rate of 650nm wavelength red light. The weak laser emitted by the product can promote the blood circulation in the macular area, improve the sensitivity of the cone cells in the fovea of the macular area, accelerate the recovery of the function of the retinal photoreceptor cells, and play an increasing role in vision; Through multi-spectral LED light irradiation, can stimulate cone cells, LED light spot automatic rotation, promote the transformation of paracentric gaze into central gaze; Through laser irradiation of the eyes save bamboo, sun, qingming, Chengqi and other twenty acupoints, can strengthen local blood circulation, improve immune function, regulate function, promote cell growth. It is used for adjunctive treatment of amblyopia (including ametropia amblyopia, anisometropia amblyopia and strabismus amblyopia) and myopia patients aged from 3 to 16 years. Classification code: 16-05.
forty-eight Myopia laser therapy instrument: it is composed of main control circuit, laser diode, exiting and shaping optical path, pupil distance adjustment mechanism and shell. Claimed that the use of red light (laser wavelength of 650nm, laser power of 0.4MW, 7.7mm diameter spot) to illuminate the fundus, improve the fundus blood circulation, promote the secretion of dopamine retinal pigment epithelial cells, so that the thinning of the choroid back to normal, while providing enough oxygen to the sclera, inhibit the abnormal growth of the eye axis. It is used to control the increase of axial length and prevent myopia in adolescents. Use twice a day for 3 minutes each time. Classification code: 16-05.
forty-nine Structure of implant repair abutment or implant abutment: When using pure titanium or titanium alloy material, finished base stations or on the base of a structure of Angle and height is improper, according to the doctor from the patients with oral cavity model, by the production enterprise purchase finished base stations or on the base of a scanned image generated data, followed by design, made by cutting and grinding, made after the direct sales to the medical institutions. When used, it is placed in the implant or abutment to connect, support and reposition the prosthesis (crown, bridge) to restore the shape and function of the missing tooth. Classification code: 17-08.
fifty Implant repair sleeve and screw: it consists of repair sleeve and screw. Made of titanium alloy material. Non-sterile products for disposable use shall be sterilized by the user organization according to the instructions before use. In the process of immediate dental implant and delayed temporary restoration, the restoration sleeve is connected with the temporary denture of implant restoration, as a part of the temporary denture, so as to facilitate the connection between the temporary denture and abutment. The temporary denture is then secured with screws to the composite abutment above the implant to protect the implant superstructure or abutment. Classification code: 17-08.
(51) Tooth whitening gel: made of 16% urea peroxide (equivalent to 6% hydrogen peroxide), polyethylene glycol, polyethylene pyrrolidone, glycerin, peppermint oil (taste correction). Use with dental cold light whitening instrument. Apply directly to the tooth surface and gargle after use. The stain is removed through a chemical reaction between the oxygen atoms released by the hydrogen peroxide contained in the product and the pigment on the tooth surface. Used for normal adults to remove stains and whiten teeth. Classification code: 17-10.
(52) resin surface finishing agent: composed of methyl methacrylate, dimethacrylate isocyanate, silica, 4-methoxophenol, polymethyl methacrylate, 2,4 diethyl thiazolone. It is used to coat the surface of dental resin restorations and denture base materials and form a film after light curing to enhance the surface finish of dental resin restorations and denture base materials. After curing, the product will enter the body with the resin prosthesis and denture base. Classification code: 17-06.
(53) Resin materials for 3D printing of orthodontic support blocks and dental models: composed of methacrylate oligomers, methacrylate monomers, free radical initiators, alumina, zirconia, silane coupling agents. The products are sold to medical device manufacturers, who manufacture dental models and orthodontic support blocks through 3D printing process. The printed orthodontic support block can be used with the orthodontic appliance to strengthen the firmness of the occlusal point between the orthodontic appliance and the tooth, ensure that the patient has enough support force when occlusal, improve the orthodontic efficiency and shorten the orthodontic time. Classification code: 17-10.
(54) Cell electroporation syringe: it consists of a base station, a handle, a needle (array), a power supply and a flash disk, and does not contain drugs or cartridges. Needle assemblies are disposable sterile products. Install the cartridge containing the medicine on the product when using. Both for intramuscular injection of the drug Inovio DNA plasmid and electroporation of the cells using a millisecond electric field applied by the needle claim to enhance the uptake of the Inovio DNA plasmid. Classification code: 14-01.
(55) Ultrasonic ablation therapy instrument: it consists of a host machine and an ultrasonic treatment head. The ablation of cervical atherosclerosis with ultrasonic energy is used in the adjuvant treatment of carotid atherosclerosis. Classification code: 01-01.
(56) Ultrasonic skin treatment apparatus: composed of a console and an operating handle. When used, the handle emits ultrasonic waves to the dermis of the skin, stimulating the growth of elastin and collagen fibers in the skin tissue, resulting in skin tightening and improving facial fine lines and wrinkles. Skin tissue degeneration may be caused during use. Classification code: 01-01.
(57) Plasma radiofrequency ablation head: consisting of a subneedle assembly, a limit ring, a handle, a cable, and a positioning sleeve. Sterile product, disposable. In radiofrequency ablation nucleus pulpoplasty, it is used in conjunction with radiofrequency therapy equipment to transmit current from the host of radiofrequency therapy equipment to the soft tissue of intervertebral disc for ablation, coagulation and hemostasis. Classification code: 01-03.
(58) Internal shockwave valve therapy instrument: it is composed of host, handle cable, shockwave valve expansion catheter and pulley support. When used, the energy output from the host acts on the calcified part of the patient's coronary vessels, causing the cracking and fragmentation of calcified plaques. It is used to treat coronary artery calcification. Classification code: 01-06.
(59) Navigation system for artificial hip replacement: infrared tracking system (including fixing nails, infrared tracking cameras, infrared reflective brackets, camera caps, camera placement tables and software); The positioning tools for hip arthroplasty (femoral platform, metal horizontal rod, femoral round table, fixing nail, fixing screw, V-shaped magnetic seat, probe) are composed. It is used for real-time positioning of the implant during hip replacement. Classification code: 01-07.
(60) Breast biopsy rotation sampling equipment: it is composed of buttons, gun body, display screen, buckle, micromotor and wireless module. When used, the product is connected to the biopsy needle, and the biopsy needle is punctured to the location of the lesion under the guidance of ultrasound equipment. It is used in conjunction with biopsy to carry out spiral biopsy sampling of breast tissue with abnormal imaging examination or palpation examination. Classification code: 01-10.
(61) Breast circumferential needle: it consists of a needle body, a protective sleeve, a handle, a tissue collector, a guide basket and a needle guide. Sterile products. For use, the product is inserted into the breast under ultrasound guidance after being connected to the circumferential system to extract tissue samples. Breast tissue samples were obtained for adjunctive histological examination. Products can be used together with a variety of ultrasonic guidance function of the rotary cutting system host. Classification code: 01-10.
(62) Ultrasonic fat dissolving apparatus: it consists of a host machine, a vacuum system, an ultrasonic system and an ultrasonic handle. Through ultrasonic action, destroy cellulite, promote fat cell apoptosis and promote metabolism, reduce local excess fat. Adjunctive treatment of obesity. Classification code: 01-01.
(63) Lung washing machine: it consists of a base, a support arm, a lung washing liquid thermostat, a head, an air injection pump, a liquid injection pump, a liquid extraction pump, a lung washing liquid pipeline, a double-cavity bronchial connection pipeline, a waste liquid bottle, a ventilator interface, a cleaning pipe interface and a pressure sensor interface. Air injection, fluid injection and fluid extraction were performed on the lungs of patients with pneumoconiosis to clean the abnormal substances deposited in alveolar cavity and bronchiole of patients with pneumoconiosis, so as to achieve the effect of lung washing. It is used in the operating room and bronchoscopy room of medical institutions. Classification code: 01-00.
(64) Special needle for radioactive seed implantation: it consists of needle tube, needle holder, lining core, lining core holder and limit ring, and is used in conjunction with the radioactive seed implantation device to implant radioactive seed to the tumor target location. Classification code: 05-04.
(65) Radioactive particle drainage catheter: it consists of main tube, developing ring, tee and pull wire. The main tube is composed of a nuclide cavity and a drainage cavity (including a drainage hole). When used, the bile can be connected to the drainage bag, and the bile can be drained to the body or duodenum through the drainage cavity of the main tube through the patient's internal pressure or external negative pressure. The side lumen of the main tube can provide a channel for placing radioactive seed iodine, which can be introduced into the clinical use. It is used for bile drainage by percutaneous insertion into the lumen of human body, and at the same time, it can provide a channel for the introduction of radioactive iodine seed. Classification code: 05-04.
(66) Radioactive seed bearing device for eye: it consists of an applicator, a suture hole and a groove. In the treatment of intraocular tumors, the radioactive seeds are implanted into the sclera of the patient for 7-30 days and removed after completion of treatment. Used in conjunction with radioactive seeds to carry and immobilization seeds during intraocular tumor surgery in seed radiotherapy. Classification code: 05-04.
(67) Cervical implant fixing plate applicator: consisting of a cylindrical implant template assembly, a vaginal depth adjustment plate assembly and a fixing band, without radioactive source. It is used for vaginal dilation in brachytherapy of gynecological cervical tumors and provides a pathway for intrauterine radiation therapy. Classification code: 05-04.
(68) Radiotherapy positioning system: consisting of an X-ray high pressure generator, an X-ray ball tube, a dedicated X-ray image detector and operating software. After the patient is fixed to the preset position, the system and the accompanying imaging hardware take the image of patient positioning, which is sent to the external image processing software as a standard image and compared with the standard image, to assist the doctor to determine the posture deviation. It can be used to monitor patient positioning during radiotherapy and provide image basis for the accuracy of radiotherapy positioning. Classification code: 05-04.
(69) Infusion connection line: it consists of connection hose, luer joint, extension pipe and three-way valve. One end of the product can be connected with a variety of radioactive drug injection equipment, and the other end of the product can be connected with other infusion equipment through the Luer joint pipeline for infusion of patients. It is used to assist the radioactive drug dispensing injection equipment to transport radioactive drugs to infusion equipment and to inject patients. Classification code: 06-12.
(70) Capsule endoscope: by transparent cover, shell, lens, circuit device, battery composition. The product enters the human digestive system from the oral cavity and esophagus, takes photos during the movement of the human digestive tract, and transmits the image data wirelessly to the external receiving device to receive the image data. Used to collect and view images of the stomach and small intestine. Classification code: 06-14.
(71) Capsule endoscope attitude controller: it consists of capsule endoscope control equipment (including magnetic head, display screen and console), capsule endoscope control software and film reading software. When used, the product exerts tension and torque forces on the capsule endoscope swallowed by the human body, driving the capsule endoscope to roll, rotate and tilt in the stomach cavity or colon. It is used for motion control and posture adjustment of capsule endoscopy. Classification code: 06-16.
(72) Ultrasonic remote operating system: composed of doctor side and patient side. Doctor side includes structural components, operation control system, audio and video system, doctor side software; The patient side includes structural components, motion execution system, audio and video system, and patient side software. Doctors can use this product for remote operation of the robotic arm to realize ultrasound scanning of patients, and can transmit and display ultrasound images. It is used to assist remote clinical ultrasonic diagnostic examination of adult patients. Classification code: 06-00.
(73) X-ray bone age testing equipment: it consists of a radio-generating device, an X-ray image detector, a computer console and software. When using the product, the child's palm and wrist are irradiated by the X-ray products to obtain images. The convolutional neural network algorithm of the software is used to process the images, and the specific conclusion of the closure degree of epiphysis is given to assist in the judgment of bone age. It is used for auxiliary diagnosis and analysis of bone age in children. Classification code: 06-00.
(74) By nerve monitoring ablation electrode/tracheal catheter: it consists of three parts: probe ablation electrode, nerve monitoring tracheal catheter and subcutaneous needle. The probe ablation electrode consists of surgical electrode, probe electrode, handle, cable and electrode protective sleeve. The tracheal tube for neural monitoring is composed of a capsule, a contact electrode, a tube body, an aerated tube, an indicating balloon, an electrode connecting wire, a contact electrode plug and a tracheal tube connector. The hypodermic needle consists of a needle body, a needle handle, an electrode connector and a connector plug. It is used to monitor nerve activity in the larynx during thyroid surgery, and perform electrocoagulation, electroresection, hemostasis and ablation of the surgical site. Classification code: 07-04.
(75) Difficult airway screening instrument: consists of an image acquisition system, computer and software. The patient's head and neck image is collected by the camera, and the software uses artificial intelligence technology to identify and analyze the patient's head and neck image, and determine whether the patient has a difficult airway. It is used to assist in determining whether patients have difficult airway. Classification code: 07-09.
(seventy-six) have a blood pressure sensor: the syringes (including the cork puncture outfit, cases, bucket, regulating valve, drops road), pressure signal output end of the wire, filling valve, sensor, three-way valve, screw syringes, silicone sheath, fixed plate, in pursuance of valve, transmission line, protective cap, plug cap, joint and the color code. It can be used together with the invasive blood pressure monitoring host to measure the arterial pressure and central venous pressure of patients through the pressure conduction of the chip, and the proximal blood with drug residue can be temporarily stored in the blood storage bypass during clinical blood collection. The arterial blood pressure and central venous blood pressure of the patient are measured, and the storage bypass is used to temporarily store proximal blood containing drug residues. Classification code: 07-10.
(77) Deep brain electrode: consisting of electrode point array, wire, plug, fixing nut and guide screw. It is surgically implanted in the patient's brain for less than 30 days. Used for auxiliary eeg monitoring equipment to monitor eeg signal and epileptic abnormal EEG signal. Classification code: 07-10.
(78) Endotracheal intubation for intraoperative nerve monitoring: it is composed of tube body, contact electrode, electrode connecting wire, contact electrode plug, inflatable capsule, inflatable tube of capsule, joint and subcutaneous needle. After the product is inserted into the trachea, the contact electrode generates an electric current to act on the nerve, and the nerve contraction stimulated by the electric current is recorded to help identify and locate the nerve. It is used for intraoperative nerve monitoring. Classification code: 07-10.
(79) Intraoperative nerve stimulation electrode: consisting of electrode tube, connector, heat shrinkable tube and cannula. In the neurosurgery of brain nerve regulation operation, it is used with nerve monitoring equipment host. Contact the patient's intracranial specific nerve nuclei in the use, the electrical signal output by the host is transmitted to the brain nerve cells for stimulation. Classification code: 07-10.
(80) Pulmonary artery floating catheter: it consists of catheter, thermistor, thermistor guide wire, optical fiber, optical module connection port, distal cavity port, injection/infusion cavity port, thermistor connection port, thermistor connection port, thermistor connection port, balloon filling valve and balloon/balloon. Sterile products for single use. In conjunction with the patient monitor, it enters the patient's pulmonary artery. Used as an adjunctive measure of right heart and pulmonary artery pressure, cardiac output, mixed venous oxygen saturation, and end-diastolic volume. Classification code: 07-10.
(81) Disposable nerve probe: consisting of probe, steel tube, handle, wire, connecting wire and probe sleeve. During the operation, the current generated by the host of the active monitoring and monitoring equipment is transmitted to the nerve through the product, which stimulates the body's nerves. It is used to stimulate the nerve during neurosurgery and assist in the diagnosis and monitoring of nerve function during surgery. Classification code: 07-10.
(82) An invasive blood pressure sensor with a closed blood collection system consisting of a pressure sensor, a perfusion device, a blood collection valve, a screw syringe, a transmission tube and a protective cap. Combined with the invasive blood pressure monitoring host, the patient's arterial pressure and central venous pressure can be measured through the pressure sensor. The perfusion device and blood collection valve can be used to collect blood samples. It is used to measure arterial pressure, central venous pressure and closed blood collection of patients. Classification code: 07-10.
(83) Ventilator system: ventilator host, power adapter, temperature probe, blood oxygen sensor, ecg main cable, ecg wiring, blood pressure cuff, CARBON dioxide gas sampling tube, carbon dioxide transfer connector, heating kit, portable handheld ultrasound module, stretcher holder and infusion rod. Ventilator host machine can provide ventilation assistance for patients, for life support; At the same time, the temperature probe, blood oxygen sensor, ecg wiring, blood pressure cuff and carbon dioxide sampling tube connected to the host are used to monitor the patient's temperature, blood oxygen saturation, pulse rate, ecg waveform, heart rate, blood pressure and carbon dioxide concentration at the end of breath with multiple parameters and alarm prompt for parameter abnormality. Abdominal ultrasound imaging and fluid infusion can also be performed. Classification code: 08-01.
(84) The plexus stimulator consists of a host, a probe electrode and a connecting wire. In anesthesia operation with probe electrode or peripheral nerve plexus stimulation needle. It is used to assist medical staff in locating peripheral nerve plexus, facilitating subsequent peripheral nerve plexus stimulation needle injection of narcotic drugs and nerve block. Classification code: 08-02.
(85) Hydrogen and oxygen treatment instrument: it is composed of an electric control system, a water tank (including water ion exchange resin purified filter element), a hydrogen and oxygen generation module, a cooling fan, a conveying pipe and a shell. Pure water is electrolysed to produce hydrogen and oxygen for inhalation. Oxygen can be used to help patients with breathing difficulties to carry out spontaneous breathing, maintain cardiopulmonary function, relieve the patient's cardiopulmonary burden. Hydrogen can be used to improve the oxidative damage of type ⅱ alveolar epithelial cells caused by high oxygen, thus playing a protective role in lung injury. Classification code: 08-00.
(86) Medical hydrogen production machine: it consists of an electric control module, a water electrolysis cell module, a gas-water separation device, a water tank, a humidifying cup and a breathing line. Water is electrolysed to produce hydrogen, which is inhaled through a breathing tube. Adjunctive therapy for adult patients with stable chronic obstructive pulmonary disease. Classification code: 08-00.
(87) Dysphagia evaluation and treatment system: consists of host, electrical stimulation expansion module, endoscope expansion module, cart, catheter electrode, power cord, controller, electrode wire, electrode plate and electronic nasolaryngoscope. The product has myoelectric acquisition, electrical stimulation (neuromuscular electrical stimulation, pharyngeal induction electrical stimulation) and endoscopic imaging functions. For the evaluation and adjunctive treatment of dysphagia caused by neurological or structural lesions (stroke, traumatic brain injury, Parkinson's disease, radiation diseases, brain tumors, Guillain-Barre syndrome, polymyositis, chorea, and oropharyngeal surgery). Classification code: 09-01.
(88) Semiconductor laser photodynamic therapy instrument: it consists of a host, optical fiber (microlens optical fiber) and accessories. The host consists of a master control module, a semiconductor laser module, a power supply driver module and embedded software. The accessories consist of a foot switch, an interlock switch and goggles. Photosensitizer is applied to the external genital lesions (the application product does not contain photosensitizer), and the strong laser (class 4 laser) emitted by the product is used to irradiate the lesions. Used with specific photosensitizer to assist the treatment of condyloma. Classification code: 09-03.
(89) Extracorporeal shock wave therapy apparatus: consisting of a mainframe, an impact pistol and a treatment probe. Using compressed air to generate shock wave, used in the auxiliary treatment of male sexual dysfunction. Classification code: 09-04.
(90) External counterpulsation therapy instrument: it is composed of host, pressure wave sleeve, expectoration vest, emergency stop hand controller and capsule sleeve. The host consists of a control circuit, an electric cylinder, a cylinder, a miniature air pump, a fan, a storage tank, a cooling fan and a solenoid valve. The product has three functions, namely external counterpulsation therapy function, air pressure wave physiotherapy function, whole chest oscillation sputum elimination function. Adjunctive therapy for ischemic diseases. Classification code: 09-04.
(91) Penile therapy device: consisting of a negative pressure pump, cylinder, inserter and tightening ring, without lubricant. When used, set on the penis, through the negative pressure pump to produce negative pressure, so that the penis cavernosa blood perfusion increased, so that the penis erection. Used to assist male patients with penile erectile dysfunction. Classification code: 09-04.
(92) Brain neuromagnetic therapy instrument: composed of a chassis, a hover frame, an operating table, a magnetic field generator and a display screen. Using the principle of biomagnetism, the magnetic field stimulation produced by the product can dilate blood vessels, enhance the blood flow and metabolic function of brain vessels, and improve the blood circulation system of cerebrovascular. It is used for auxiliary treatment of anxiety disorder and insomnia. Classification code: 09-05.
(93) Transcranial ultrasound head: it is composed of a transducer, a transducer housing, a cable and a plug, provided non-aseptically, and used in combination with a variety of transcranial ultrasound neuromuscular stimulation devices to apply ultrasound at a specific frequency and power through the skull to the brain tissue, so as to take advantage of the biological characteristics of ultrasound for treatment. Classification code: 09-06.
(94) Radiofrequency ablation needle-like electrode: consists of a connector, a wire, an electrode, a housing and a handle. When used in conjunction with radiofrequency fat melting equipment, the electrode invades the patient's skin tissue and outputs radiofrequency energy to coagulate and apoptotic fat cells under high temperature, assisting radiofrequency fat melting. Classification code: 09-07.
(95) External capacitance field hyperthermia machine: it is composed of host [high frequency source (including electrode)], bed body and operating table. Hyperthermia is performed deep and shallow in the prostate and pelvic cavity through thermal and non-thermal effects generated by high-frequency capacitance fields. For chronic prostatitis, benign prostatic hyperplasia, chronic pelvic inflammatory disease adjuvant treatment. Classification code: 09-07.
(96) Biofeedback therapeutic apparatus: it is composed of computer host, monitor, collector (including eeg, EMG, skin electrogram, ECG, heart rate, respiration and temperature signal collection), electrode wire plate and special software. Through the collection and analysis of human physiological indicators (eeg, heart rate variability and electromyography related indicators), according to the collected physiological indicators parameters combined with training games to assist patients to carry out relevant training, in order to control the brain function, so as to achieve the purpose of relieving and treating anxiety, depression, insomnia, attention disorders. Adjunctive therapy for insomnia, ADHD, anxiety and depression. Classification code: 09-08.
(97) Medical oxygen treatment chamber: it consists of a treatment chamber, a supply/exhaust system, an oxygen supply/exhaust system, an air conditioning or cold drying system and an electrical system. By providing high pressure and high concentration oxygen environment for patients, it is used for auxiliary treatment and rehabilitation of patients with ischemic and hypoxic diseases. Classification code: 09-08.
(98) Brain function therapy instrument: it is composed of host, magnetoelectric unit [magnetic therapy cap (belt), main electrode], magnetic unit [magnetic therapy cap (belt)] and electrical unit (main electrode, auxiliary electrode). The magnetic cap is worn on the head, the main electrode is placed on the mastoid epidermis behind the ears, and the auxiliary electrode is placed on the limb or other parts of the body. Magnetic units act on brain cells and cerebrovascular cells through the output of alternating electromagnetic fields with specific laws. Electrical unit through electrical stimulation of the cerebellar parietal nucleus, to dilate brain blood vessels, improve the brain microcirculation; To improve the conduction function of the nervous system and promote the rehabilitation of atrophic muscles and nervous system through electrical stimulation of the muscular nervous system of the affected limb (including the paralyzed part). It is used for auxiliary treatment of ischemic cerebrovascular diseases, brain injury diseases, children cerebral palsy, neurosis (anxiety disorder, depression, neurasthenia, insomnia, brain fatigue). Classification code: 09-00.
(99) Medical air pressurization chamber: consisting of a sealed chamber and an air pressurization system. The sealed chamber is a steel atmospheric pressure vessel composed of the main cabin, Windows, doors and transition cabins. Air supercharging system provides compressed air source, which consists of supercharging fan, heat exchanger and air filter. Through the air pressurization system, the outdoor air is pressurized and conveyed to the sealed cabin to improve the cabin pressure and simulate the low-altitude air environment. Used to assist in relieving symptoms of altitude sickness after entering high altitude areas. Classification code: 09-00.
(100) Plasma therapeutic apparatus: it consists of a circuit control, a boost device, an electrode, a jet nozzle and a shell. During treatment, the jet nozzle is placed close to the affected area, and the pressure booster device of the product generates a high-intensity electric field and forms plasma through discharge, which is used to promote wound healing and stimulate skin cell regeneration. Classification code: 09-00.
(101) Transcranial therapy instrument: it is composed of host, alternating magnetic field (transcranial magnetic field) therapy body, brain treatment electrode, limb treatment electrode and output line. Transcranial magnetic therapy (TMS) is performed by wearing an alternating magnetic field (TMS) body on the head; Frequency modulated and amplitude modulated low frequency electrical pulses were used to stimulate the cerebellar parietal nuclear power, which was applied to the protruding area parallel to the ear canal to improve blood circulation in the brain. Low frequency modulation medium frequency electrical stimulation on motor dysfunction (including paralysis), can be caused by cerebrovascular disease of limb movement disorders rehabilitation treatment. For ischemic cerebrovascular disease, neurosis (including anxiety, depression, fear, obsessive-compulsive disorder, neurasthenia) adjuvant treatment. Classification code: 09-00.
(102) Blood irradiation/oxygenation equipment: it consists of ultraviolet light source, oxygen supply system, mechanical transmission system and program control system. When used, the blood bag containing oxygenated isolated blood is irradiated by ultraviolet light after being filled with an appropriate amount of oxygen through the oxygen inlet tube of the blood bag. Used for oxygenation and irradiation of bagged blood. Classification code: 10-01.
(103) Peristaltic pump for blood extracorporeal circulation pipeline: it consists of a shell, a display screen, a main board, a stepping motor, a bracket, a roller and a button. In the process of blood extracorporeal circulation, it provides auxiliary power for the blood flow in the blood extracorporeal circulation pipeline. Products do not come into contact with patients, do not come into contact with blood. Classification code: 10-03.
(104) Radiotherapy recording and validation system software: After the radiotherapy plan data is imported into the software, the software calculates the dose of the treatment planning system and verifies that the beam transmission parameters match those defined in the treatment planning system. Used for secondary dose calculation of radiation therapy plan data and validation for comparison of radiation therapy parameters. Classification code: 21-01.
(105) Intelligent positioning software for brachytherapy: The software generates the model of insertion needle source by importing CT or MR images of the patient's pelvis and abdomen. In the brachytherapy of cervical cancer, the auxiliary injection model and needle path design, and the generation of insertion needle injection model. The insertion needle and post-installation therapy machine can accurately locate the needle through the needle path designed in the customized emitter, improving the efficiency of radiotherapy. To assist in completing radiotherapy. Classification code: 21-01.
(106) Radiation therapy plan validation software: software product. Use before and during radiation therapy. The software can ensure the safety of radiation therapy by calculating dose maps based on patient treatment plans, analyzing log files generated during radiation therapy, and verifying the dose for a specific patient. Used to compare the current and preset parameters of the radiotherapy machine and to record data for the actual treatment stage before the commencement of planned radiotherapy and before the commencement of each treatment stage. Classification code: 21-01.
(107) Orthopedic surgery planning software: The software provides a reference for orthopedic surgery planning by measuring the length and Angle of the X-ray image and testing whether the prosthesis model matches the image. It is used to assist doctors in making surgical plans before orthopedic surgery. Classification code: 21-01.
(108) Auxiliary diagnostic software for chest diseases: after the software inputs chest DR and chest CT medical images in accordance with DICOM standard format, the software uses medical image registration technology to calculate the characteristic values of the input images, and compares them with the normal standard images built in the software. When abnormalities occur, the software prompts doctors. It is used to calculate and measure the medical image, and give the hint whether there is abnormality in the image according to the comparison with the standard image. Classification code: 21-04.
(109) Human tumor multi-gene mutation detection and analysis software: composed of sample management, experiment management, analysis management, report management, data management and system configuration modules. Used in conjunction with the Human tumor multigene mutation detection kit (combined probe anchored polymerase sequencing). The tumor mutation load (TMB) level and EGFR, BRAF, ALK, PIK3CA, MET and RET gene mutations in formalin fixed paraffin-embedded (FFPE) tissue samples from non-small cell lung cancer (NSCLC) patients were obtained by analyzing kit detection data, and the results were compared with the criteria. Classification code: 21-04.
(110) Cervical cell automatic analysis and screening software: after the software reads the digital image of cervical fluid based cytology smear, it uses machine learning algorithm to make statistics on the shape and color characteristics of the image, extract the characteristic values, calculate the probability of cytopathic changes, and thus mark the image of possible lesions. It is used for computer aided analysis and interpretation of cervical cytology on digital cervical smear image, detection and marking of suspicious areas in the image. Classification code: 21-04.
(111) CT image pulmonary nodules analysis and evaluation software: After reading CT images, the software uses deep learning algorithm to analyze and process the images, identify the information suspected of pulmonary nodules, and finally give the diameter, mass, volume and CT value of pulmonary nodules. It is used to display, process and recognize lung CT images and assist doctors in the evaluation of pulmonary nodules. Classification code: 21-04.
(112) Auxiliary calculation software for blood transfusion: it consists of five modules: patient management, blood use management, blood type identification, blood bank management and basic information management. Software for patients' ABO blood group identification results and Rh5 phenotype of factor appraisal result after blood transfusion related information, using its own unique algorithm, after calculation, get the current sample can choose blood product outbound compatibility value, and matches the value by high arrangement, for laboratory operations staff to choose suitable adjuvant therapies for patients blood transfusion. Classification code: 21-04.
(113) Human Multi-gene Mutation Detection Kit analysis software: The software was used in conjunction with the sequencing kit to calculate the effective DNA sequence data of specific fragments of multiple genes (EGFR, ALK, ROS1, KRAS, NRAS, PIK3CA, ERBB2, BRAF, MET, RET and NTRK) and obtain the corresponding reference sequence alignment results. The information analysis results of point mutation (SNV), insertion deletion mutation (Indel), copy number variation (CNV), Fusion variation (Fusion), microsatellite instability (MSI) and tumor mutation load (TMB) were obtained. It was used to analyze point mutation (SNV), insertion deletion mutation (Indel), copy number variation (CNV), Fusion variation (Fusion), microsatellite instability (MSI) and tumor mutation load (TMB). Classification code: 21-04.
(114) Chest medical image analysis and screening software: Software reads the DICOM standard format (DR, CT) chest medical image, deep learning algorithm was used to construct the tumor disease, tuberculosis disease, inflammatory diseases, fracture and calculation model of diseases such as heart disease, according to the input of medical imaging, through calculation and analysis of positive and negative probability of related diseases. Classification code: 21-04.
(115) Blood cell morphology analysis software: Software after reading blood cell image, using the deep learning algorithms for image processing and analyzing of blood cells for identification, classification, identify the lymphocytes and neutrophils, monocytes, eosinophils, basophils, reticulocyte, red blood cells, platelets, assist doctors for blood disease diagnosis. Classification code: 21-04.
(116) Sperm morphology analysis software: after reading the sperm image, the software uses the deep learning algorithm to analyze and process the image, identify, analyze and count the activity and morphology of sperm, and determine whether there is abnormal sperm morphology (abnormal head, neck and middle section). It is used for sperm morphological evaluation such as sperm activity and morphological recognition to assist doctors to judge the reproductive ability of male patients. Classification code: 21-04.
(117) Oncoprotein activity analysis software: Software using the algorithm of enterprise characteristic of tumor samples of sequencing data quality control, filtration, alignment, such as processing, and through analyzing the processing results of the active, many kinds of cancer associated protein active analysis results, and according to the cancer protein activity related technical indexes in the database matching the one or more targeted drugs, assist doctors to match tumor targeted drugs. It is used to analyze the activity of cancer-related proteins and assist doctors in matching tumor targeting drugs. Classification code: 21-04.
(118) the digestive endoscope image processing software, the software read digestive endoscope image from the image processing device, deep learning algorithms for gastrointestinal endoscopy image analysis and processing, identify the image of bleeding, polyp of the stomach, suspected tumor lesions and intestinal colorectal polyps and adenomas of the anomaly, and prompt medical personnel. It is used for analysis and processing of gastrointestinal endoscopy image, recognition and warning of abnormalities in the image. Classification code: 21-04.
(119) Chromosome analysis software: After reading the chromosome image, the software uses the deep learning algorithm to analyze and process the image. After identifying and dividing the chromosome contour, the software uses the deep learning algorithm to classify and sort the identified and segmented chromosomes. It is used for chromosome identification, segmentation, classification, sorting and other chromosome karyotype analysis to assist doctors to judge whether patients have chromosome abnormalities. Classification code: 21-04.
(120) cervical liquid based cell analysis software: software, after reading chromosome image analysis of image processing with deep learning algorithms, cells of cervical liquid based identification, classification, give no intraepithelial lesions or malignant lesions, abnormal epithelial cells and microbial infection, atypical squamous epithelial cells, etc. It is used for the recognition and classification analysis of cervical fluid based cells and to assist doctors in the diagnosis and screening of cervical cancer. Classification code: 21-04.
(121) Image-assisted diagnosis software for sarcopenia: the software collects craniofacial images of patients, and uses deep learning algorithm to carry out THREE-DIMENSIONAL reconstruction, data analysis and processing of craniofacial images, and gives the diagnosis results of sarcopenia. Classification code: 21-04.
(122) Cervical cytology digital pathological image computer aided diagnosis software: after the software reads the pathological image of cervical smear, the deep convolutional neural network algorithm is used to segment the nucleus in the image to obtain the location of the nucleus in the image, and then obtain the small cell image. It is used to segment cervical cytological digital pathological images to obtain the location and classification of abnormal cells and assist pathologists in the diagnosis of cervical cells. Classification code: 21-04.
(123) Auxiliary diagnosis software for colorectal cancer: The software reads the mRNA sequencing data of the second generation of colorectal cancer tissue samples of patients, analyzes the data by machine learning algorithm, predicts the risk of colorectal cancer, and provides the auxiliary diagnosis results of early colorectal cancer, advanced colorectal cancer, polyp and no colorectal cancer. Adjuvant results for colorectal cancer. Classification code: 21-04.
(124) Automatic auxiliary grade management system for bone age and epiphysis: after the software reads the X-ray image of the left wrist of the child patient, artificial intelligence algorithm and big data technology are used to process and analyze the image based on the maturity and morphological characteristics of epiphysis, and finally the automatic grade of bone age and epiphysis is obtained. It is used to grade children's bone age epiphysis and assist in evaluating children's development. Classification code: 21-04.
(125) Multi-gene mutation analysis software for human solid tumor: Used in combination with software and accessory kit, through will have a sequencing of gene sequencing machine, compare the original data file with the reference genome sequences, using bioinformatics method to analyze a variety of genetic variation types, get single nucleotide mutation and insertion/deletion mutation, rearrange (fusion) and copy number variation result of amplification, Genomic microsatellite instability (MSI) and tumor mutation load (TMB). To obtain the results of multiple tumor variation analyses for point mutation, insertion deletion mutation, rearrangement (fusion), copy number variation, microsatellite instability (MSI) state and tumor mutation load (TMB). Classification code: 21-04.
(126) Ecg analysis software: Software receiver static ecg and dynamic ecg or ambulatory blood pressure data, the deep learning algorithm for ecg data processing, analysis, given the electric axis deflection, atrial hypertrophy, ventricle hypertrophy, atrioventricular block, indoor conduction block, ST -t change disease, myocardial infarction and arrhythmia (including atrial fibrillation, etc.), such as automatic analysis results. It is used to collect, analyze and process ecg data, and give the analysis results of arrhythmia, ST-T abnormality, myocardial infarction diseases, atrial hypertrophy, ventricular hypertrophy, etc. Classification code: 21-00.
(127) An auxiliary diagnostic system for mental diseases: it consists of a camera, a monitor, a mainframe and software. Through artificial intelligence and big data technology, the collected physiological parameters of patients were extracted, modeled and analyzed, and finally the results of depression, anxiety, schizophrenia and other mental diseases were given as asymptomatic, moderate and severe symptoms. It is used for auxiliary diagnosis of depression, anxiety, schizophrenia and other mental diseases. Classification code: 21-00.
(128) Human papillomavirus quality control products: human cervical cancer cell lines containing single type of human papillomavirus (HPV) sequence, composed of positive quality control products (HPV16, 18, 31, 33, 45, 52, 58, 68, 6, 11) and negative quality control products. Clinical quality control and evaluation of nucleic acid testing and genotyping kits. Classification code: 6840.
(129) Human papillomavirus quality control products: human cervical cancer cell lines containing single type of human papillomavirus (HPV) sequence, composed of positive quality control products (HPV16, 18, 31, 33, 45, 52, 58, 68, 6, 11) and negative quality control products. Clinical used for indoor quality control in various laboratories. Classification code: 6840.
(130) Kappa reagent (flow cytometry) : composed of Kappa monoclonal antibody reagent. It is used to detect the expression of Kappa in human biological specimens and is clinically used for the analysis of leukemia and lymphoma. Classification code: 6840.
(131) Lambda detection reagent (flow cytometry) : composed of Lambda monoclonal antibody reagent. It is used to detect the expression of Lambda in human biological specimens and is clinically used for the analysis of leukemia and lymphoma. Classification code: 6840.
(132) Programmed death receptor ligand 1 (PD-L1) antibody reagent (immunohistochemistry method) : consists of programmed death receptor ligand 1 (PD-L1) monoclonal antibody and antibody diluent. Immunohistochemical staining was performed on the basis of routine staining to guide the medication of non-small cell lung cancer. Classification code: 6840.
(133) CD19 detection reagent (flow cytometry) : consists of fluorescein labeled CD19 monoclonal antibody reagent. It is used to detect the expression of CD19 in human biological specimens for leukemia and lymphoma analysis. Classification code: 6840.
(134) CD20 detection reagent (flow cytometry) : consists of fluorescein labeled CD20 monoclonal antibody reagent. It is used to detect the expression of CD20 in human biological specimens for leukemia and lymphoma analysis. Classification code: 6840.
(135) CD138 assay (flow cytometry) : consists of fluorescein labeled CD138 monoclonal antibody reagent. It is used to detect the expression of CD138 in human biological specimens for leukemia and lymphoma analysis. Classification code: 6840.
(136) CD117/ C-kit antibody reagent (immunohistochemistry) : it is composed of CD117/ C-kit antibody reagent. It is used for medication guidance of gastrointestinal stromal tumor. Classification code: 6840.
(137) CD20 antibody reagent (immunohistochemistry) : it is composed of CD20 antibody reagent. It is used to guide the medication of lymphocyte-derived tumors. Classification code: 6840.
(138) Single-use digestive system excellular sampler: consists of medical hollow capsule, sponge, wire and cell preservation solution. Non sterile provided. After the patient swallows the sample swab, the capsule shell dissolves in the stomach and the compressed polyurethane sponge is released to return to its pre-compression shape. During the process of pulling the thread out, the sponge rubs against the esophageal wall, and the exfoliated cells are scraped and put into the cell preservation solution for the collection of exfoliated cells in the digestive system. Classification code: 22-11.
(139) Disposable exfoliated cells collection capsule: consists of medical hollow capsule, sponge, wire and collection bottle containing preservation solution. Non sterile provided. The medical hollow capsule is dissolved after entering the human body, and the sponge in the capsule is released. The sponge can absorb the shed cells in the esophagus and oral cavity when the thread is lifted. It is used to collect exfoliated cells from the upper esophagus or oral cavity, and the collected cells are only used for clinical in vitro detection. Classification code: 22-11.
(140) Human PAX1 Gene methylation Detection Kit (PCR-fluorescent probe method) : consists of PCR reaction solution (including PCR reaction components, primers and probes), Taq DNA polymerase, positive and negative quality control products. It is used to detect the methylation of PAX1 gene in cervical samples, and is used in clinical diagnosis of cervical cancer. Classification code: 6840.
(141) Blood sample collection kit: it consists of a disposable negative pressure blood collection container, a disposable intravenous blood collection needle and iodophor disinfection cotton. Used to collect venous blood samples. Classification code: 22-11.
(142) CD117 antibody reagent (immunohistochemistry) : it is composed of rabbit monoclonal antibody against human CD117. Clinical guidance of drug use for gastrointestinal stromal tumor. Classification code: 6840.
(143) CD20/ KI-67 assay kit (immunohistochemistry) : Consists of CD20 antibody working fluid and Ki-67 antibody working fluid. Clinical guidance for the use of drugs in lymphocyte-derived tumors. Classification code: 6840.
(144) Library kit for second generation sequencing: it is composed of fragment buffer V2, fragment mixture V2, TE buffer, splice ligating mixture, splice ligase, splice mixture, fragment enrichment buffer V2, tag primer-1, tag primer-2, etc. It is used to process obtained human cDNA samples to generate cDNA libraries suitable for Illumina II sequencing platform. Classification code: 6840.
(145) H. pylori test Kit (immunoenhanced turbidimetry) : consists of reagent R1(phosphate buffer, polyethylene glycol) and reagent R2 (phosphate buffer, latex particles sensitized by H. pylori antigen). It is used for quantitative determination of helicobacter pylori IgG antibody in human serum in vitro. It is used for auxiliary diagnosis of gastrointestinal ulcer, routine physical examination and symptomatic gastric disease. Classification code: 6840.
(146)Gene sequencing Library kit: Consists of restriction endonuclease mixture, restriction endonuclease buffer, terminal repair enzyme mixture, terminal repair buffer, ligating mixture, ligating enhancer, amplification mixture (including high fidelity DNA polymerase, DNA polymerase buffer and universal amplification primer). It is used in conjunction with Illumina specific sequencing reagents and sequencing instruments for the construction of sequencing libraries. Classification code: 6840.
(147)Soluble B Cell Mature Antigen (sBCMA) Assay kit (Magnetic particle chemiluminescence) : Consists of reagent 1 (containing sBCMA monoclonal antibody and magnetic particle), reagent 2 (containing sBCMA polyclonal antibody), calibrator and quality control. It is used for quantitative determination of sBCMA concentration in human serum and plasma in vitro. Clinically, it is mainly used as a biomarker for diagnosis and prognosis of multiple myeloma (MM), as well as a monitoring factor for treatment response. Classification code: 6840.
(148) Liver fluke IgG Antibody Detection Kit (ELISA) : consists of coated plate, enzyme conjugate, concentrated washing solution, chromogenic agent A, chromogenic agent B, sample dilution, stop solution, positive control and negative control. Used for qualitative detection of specific liver fluke IgG antibody in human serum. It is mainly used for auxiliary diagnosis of human liver fluke infection. Classification code: 6840.
(149) Epithelial cell screening device (microfluidic chip immunoassay) : consists of microfluidic chip coated with anti-epithelial cell adhesion molecule (EpCAM) antibody, sample injection tube and buffer tube. It is used for the enrichment of circulating epithelial cells in peripheral blood, and the enriched cells are subsequently used for the auxiliary diagnosis of various solid tumors, chronic liver diseases, pancreatic cystic diseases, etc. Classification code: 22-00.
(150) Exosome quantitative assay Kit (immunoluminescence method) consists of magnetic suspension coated with CD63 antibody, secondary antibody (acridine ester labeled CD9 antibody), activator A, activator B, dilution, washing solution and calibration. It is used for quantitative detection of exosomes in serum, plasma and other body fluids as well as in separated and purified exosome body weight suspension, and is used for auxiliary diagnosis, prognostic analysis and medication guidance of tumors in clinical practice. Classification code: 6840.
(151) Circulating Tumor Cell (CTC) Detection Kit (Fluorescence immunoassay) : By the chip (monocrystalline silicon, biotin), cover plate, blood mononuclear cell concentration liquid, chip modified liquid (chain mildew avidin), capture enhanced liquid (biotinylated goat anti human epithelial cell adhesion factor), cell characterization of protein antibody (with rabbit anti cytokeratin pan antibodies, CD45 resistance in mice, the mice Pr3) antibodies, Alexa488 Labeled donkey anti-rabbit IgG, Alexa647 labeled donkey anti-mouse IgG, and nuclear fluorescence staining solution. After the samples were passed through the chip, the cells captured on the chip were stained with immunofluorescence reagent, and the image of the whole chip was obtained by fluorescence microscope. Finally, the CTC was classified, identified and counted according to fluorescence staining and cell morphological characteristics. Classification code: 6840.
(152) Intestinal tumor organ cell culture medium: it was composed of RPMI-1640 medium, gastrin, nicotinamide, ALK inhibitor and P38 inhibitor. It is used for the proliferation and culture of intestinal tumor organ cells, which has the function of selecting, inducing and differentiating the cells, and the cultured intestinal tumor organ cells are used for drug sensitivity test. Classification code: 6840.
(153) Gastric tumor organ cell culture medium: it was composed of RPMI-1640 medium, epidermal growth factor, R-spinal protein 1, head protein, WNT protein, fibroblast growth factor 10 and gastrin. It is used for proliferation and culture of gastric tumor organ cells, which has the function of selecting, inducing and differentiating the cells, and the cultured gastric tumor organ cells are used for drug sensitivity test. Classification code: 6840.
(154) Organoid tumor cell culture medium: it was composed of RPMI-1640 medium, epidermal growth factor (EGF), R-spondin-1 and Noggin. It can be used for proliferation and culture of organoid tumor cells, which has the function of selection, induction and differentiation of organoid tumor cells, and the cultured organoid tumor cells are used for drug sensitivity test. Classification code: 6840.
(155) Electric sampling navigation system: it consists of a robot trolley, a sampling actuator, a main operating platform and an isolation shield. The robot trolley is used to push it to patients for operation, the sampling executive mechanism is used to collect patients' throat swabs, the main operating platform is used to control the sampling executive mechanism by doctors, and the isolation shield is used for one-time isolation protection. Used to assist physicians in throat swab collection and nasal swab collection. Classification code: 22-11.
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