Accordance with the provisions, medical film paper, exercise with oxygen measurement systems, disposable blood towels, cooling gel, diabetic foot membrane system, periodontal dressings, anti-bedsore mats and other common products are no longer as a medical device regulation. Upon request, not as a medical device for the administration, such as the registration has been accepted yet completed the approval, the food and drug regulatory authorities should be required to refuse to register the relevant registration information to be archived. Still within the validity period of the medical device registration certificate shall not continue to use.
A

What? !
It has not yet received approval to complete the registration shall not be registered.

Still within the validity period of the medical device registration certificate shall not continue to use.

Blame me, huh?
To ensure the safety of medical devices, effective protection of human health and life safety, countries have developed “Supervision and Regulation of Medical Devices.” China Food and Drug Administration based on medical equipment production, operation, use, and timely to changes in risk medical devices for analysis, evaluation of medical devices Category adjust.

You make it?
B
, On the multi-purpose ultrasound bone knife 127 Categories defined notifications (Food and Drug Administration Office of mechanical pipe [2015] No. 104)

1, the powder inhaler Recorder: records of patients using the powder inhaler every time and date, does not indicate powder inhaler remaining amount of drug, dose calculation does not have a function.

2, the temperature control device: the controller chassis, control the heating portion embedded in the cylindrical part of the instrument chassis, temperature measuring device section, a display and control section, sterile tubes. Through internal control instruments fixed tube by adding sterile water to achieve and maintain a constant temperature of the heating function in the joint action of heat and control means for the device is only used for heating insulation.

3, wax plastic platform: in laboratory production base wax, wax is used as a plastic sleeve or the base platform.

4, adapter: connecting the host and guide the endoscope cold light beam between the endoscope and used.

5, automatic pill crusher machine: by the door, fuse box, on / off button, pill crusher special medicine cup holder, fixed tray, grinding head, the power LED, input device adapter, storage trays, for medicine crushed or ground into powder.

6, mattresses disinfection: the disinfection chamber and mechanical pipeline, used disinfecting mattresses, pillows, blankets.

7, multi-unit base body scanners: laboratory equipment. The production process used in dental restorations computer-aided design, mold fixed on the teeth to aid dental scanning machine to obtain a clear 3D image.

8, heat controller: controller host by the heat, combined heat and power lines clamp, used disposable sheath system when detached from the endoscope, disposable forceps channel tube heat sealing the endoscope.

9 Height Prediction Software: Based on the wrist X image (DICOM file) to identify the level of the wrist bone, adult height prediction.

10, electric exhaust: the AC motor and piston device component. Passing through the piston ring on the piston cylinder seals, negative pressure is generated in the course of the reciprocating motion, instead of the negative pressure tank manually exhaust vent.

11, medical film paper: the paper-based and nano-coating composition for use in medical imaging systems (CT, DR, MR, CR, DSA, US, etc.) DICOM image output generated by the output image is not a diagnosis.

12, drug washing device: Place the liquid from the container for the water through the filter means connected to the container by the pump hose and filter means connected through instant water heater and water pump connection is provided on the pipe commutation valves and spray bar for spraying liquid composition (without liquid). For anorectal surgery, genital surgery wounds medicated bath cleaning.

13, laminar air disinfection machine: the chassis, controller, frame, wheels, fans, air filters, silencers cotton and Wai file, frame, lighting, composition, wind-driven circulation system by passing air through the filter means for the local interior air filtration and purification disinfection. For cleaning and disinfection of the environment of the patient.

14, treatment with a compound such as protein: protein recombinant techniques applied to construct EpCAM-GM-CSF fusion protein, and verify its stability and toxicity. For cancer patients after treatment.

15, sample collection, carrying instruments: the sample cup, sample bags, tubes, slides, etc., is only used to collect clinical samples bearer.

16, instrument pipe cleaning fluid: water-soluble salt (potassium chloride, sodium chloride, etc.), buffering, detergent and preservative. For electrolytes, blood gas analyzer sample before analysis to detect liquid path tightness and sensor response potential (whether in the linear range), after analyzing samples rinsing liquid passage pipe.

17, sipper arm extension: the extension of the track to extend the cover composition. Specific analyzer used in conjunction with rail extended system that allows the analyzer sample arm and suction aspiration sampling head can reach a new level of suction points on third-party automated rail system, with third-party automated analyzers used in conjunction with the track system.

18, exercise with oxygen measuring system: random by the handset and software components, the sensor on the phone, users measuring blood oxygen levels and heart rate, and reached the cell phone software, the formation of the log file. For the user to view blood oxygen levels and heart rate every day, to help users understand the movement situation, does not have a clear purpose Article 76 “Supervision and Regulation of Medical Devices”, the measured data is not as a diagnosis.

Second, on the constant temperature nucleic acid amplification 22 Categories defined notification detector and other (Food and Drug Administration Office of mechanical pipe [2015] No. 75)

19, ceramic beads species preservation tube: small ceramic beads from the surface of the porous, tryptic soy broth veins, glycerol and sucrose by mixing components. Save for microbiological examination of the species.

Third, on the artificial blood vessel access 172 Categories defined ring notification (Food and Drug Administration Office of mechanical pipe [2015] No. 69)

20, thorn bracket: the bracket, handle, adjust the rod components. In clinical arteriovenous wrist puncture, placing the patient wrist.

21, ampoule is broken: by the guide sleeve, broken plates, and an elastic sheet guide plates. For broken ampoules under local airtight case, the blizzard can not splash out, the protection of health care workers.

22, disposable blood towel: the towel and the shaft constitute non-woven blood. When blood is placed under the arm’s blood, avoid direct contact with blood collection station.

23, diabetic foot membrane systems: the sponge applicator, stretch fabric stockings, anterior tibial crest / ankle / foot pads, protective cover, fixed socks, external protective footwear, paper / plastic tape composition. Mainly through the plantar pressure to disperse the leg to relieve plantar surface diabetic ulcer wounds pressure to reduce friction plantar surface for diabetic foot foot protection of patients, and also to change bad habits and the way the patient walks .

24, fixed points posted: a nonwoven fabric base lining, foam gaskets cotton, pearl impermeable membrane, acrylic coatings, release paper and non-woven cotton aqueous composition. For external fixation and external fixation treatments electrode sticking points in traditional Chinese medicine.

25, cooling gel: from liquid to gel and applicator bottles go bead composition, menthol gel made of hydroxy acid, ethanol, glycerol, water. For physical fever, cold treatments. Only for closed soft tissue.

26, hyaluronic acid nipple wipes: from sodium hyaluronic acid, olive oil emulsion and a nonwoven fabric. For the prevention and adjuvant treatment of nipple.

27, chitosan bedsores wipes: a nonwoven fabric made of the adsorption of antimicrobial colloidal solution. Antibacterial colloidal solution by the chitosan, carbomer, pyrrolidone carboxylic acid zinc, vitamin E, polyoxyethylene hydrogenated castor oil, purified water. The main use inhibit and kill pathogenic role, to prevent and treat bedsores auxiliary purposes.

28, hemorrhoids wipes Chitosan: antimicrobial colloidal solution adsorbed by the non-woven material. Antimicrobial colloid solution of chitosan, carbomer, witch hazel, menthol, purified water. The main use inhibit and kill pathogenic role, to prevention and adjuvant treatment of hemorrhoids purposes.

29, skin care wipes Chitosan: antimicrobial colloidal solution of a nonwoven fabric made of adsorption. Antimicrobial colloid solution of chitosan, carbomer, sodium chloride, aloe vera gel, purified water. The main use inhibit and kill pathogenic role for skin diseases (including skin eczema, other skin diseases caused by fungal infection tinea, athlete’s foot, ringworm and mold caused), after dry skin disease and wounds laser beam care, small area of skin wound infection prevention, the skin around the nose and runny nose caused by mucosal injury treatment and prevention. Skin can also play the role of isolation protection to prevent skin damage bacterial infections and adverse external stimuli physical, chemical, mechanical, etc. caused.

30, anti-bedsore pad: use of polyacrylic acid, peppermint oil, water gel, made of polyvinyl alcohol. For postoperative or bedridden patients to prevent bedsores.

31, latex hydrogel pad: composed of water, glycerin, cross-linked polymer. For the relief of symptoms associated with breastfeeding nipple injury-related.

32, wet dressings healing: the wound pad and polyacrylate layer. Wound pad using a silicone coated polypropylene, polyacrylate layer containing polyhexamethylene biguanides. There are trends for healing wounds and wound debridement of chronic wounds or skin ulcers. When used, it can absorb wound exudate, and the use of antimicrobial activity of polyhexamethylene biguanide, inhibiting wound bacterial growth, reducing the risk of infection. Meanwhile polyacrylate can impede the wound healing process of matrix metalloproteinase (MMP) inactivation of the healing process in chronic wounds stagnant once again been activated.

33, periodontal dressing: from perfluorodecalin, glycerol, water, emulsifying wax, hydrogenated phosphatidyl choline, vitamin E, benzyl alcohol, oxygen. For oral and periodontal surgery using perfluorodecalin high affinity for oxygen, the formation of a high concentration of oxygen, periodontal wound healing.

34, medical paste Glister: from bioactive glass, glycerin, polyethylene glycol, silica and other components. The use of bioactive glass reacts with water and saliva, releasing calcium and phosphate ions, mineral supplement tooth structure, precipitation over the dentinal tubules and crystalline hydroxyapatite layer (mineralization) within to promote dental tissue growth and induce the formation of new dental glazed. For the general population of dentin hypersensitivity, bleeding gums, plaque treatment and prevention.

35, sodium hyaluronate solution: by white enema bottle, suspension and protective cap composed of a solution of sodium hyaluronic acid, paraben, potassium dihydrogen phosphate, disodium hydrogen phosphate dihydrate, sodium chloride, eighteen alcohol, cetyl alcohol mixture, Twain composition to the water sorbitan monolaurate, preservative, xanthan gum and water for injection. When using the rectal, colonic mucosal surface of the film-like barrier for facilitating colonic natural healing, relieve mild to moderate ulcerative colitis symptoms.

36, disposable bladder irrigation package: mainly composed of the liquid storage bag, rinse, double rinse tubes. Flushing fluid is sterile water or a sterile aqueous solution containing 0.9% sodium chloride. And supporting the use of catheters for clinical bladder wash.

37, the perfusion fluid bladder: the collagen, sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate and water for injection. Provided sterile. For the temporary replacement of the bladder epithelium missing, relieve a variety of symptoms of cystitis.

38, manual chairside: the headrests, armrests, backrest and seat and chassis components. Used as a medical patient chair (excluding dentistry) institutions.

39, meaning foot and accessories: from the ankle, ankle liner, foot assembly, axial needle, needle axial screws, front bumper, rear bumper, lubricants and righteousness feet enclosure, socks, caps, EXO module package composition. Through the establishment of simulated people “foot” or ankle “joint – foot” structure that helps to install the foot prostheses for adults and children, support and restore walking function.

40, ear spray: aluminum acetate, aluminum acetyl tartaric acid, acetic acid and water. Providing high-salt environment acidic, varying the osmotic pressure, damage the cell walls of microorganisms, microbial death. For the prevention and treatment of various inflammatory external auditory canal, eczema.

41, insulation breathing mask: from the vent holes in the cover, inside cover, and fixed with a silicone gasket composition. Independently, worn on the face, covering the nose and mouth parts. For temperature appropriate to enhance breathing, respiratory warm.

42, swallowing lubricant gel: from agar, erythritol, maltitol, locust bean gum, sucrose fatty acid esters, citric acid, flavors, colors, and purified water. The gel when used to wrap the drugs, the use of gel lubrication through the esophagus and into the stomach. For assisting patients with dysphagia oral solid drugs. It can also be used for patients with dysphagia swallowing function training.

43, hematopoietic progenitor cells, stem cell storage pouch: for storage of hematopoietic progenitor cells can be directly used in clinical stem cell.

44, birth canal DRA: consisting of propylene glycol, hydroxyethyl cellulose and the amount of water for injection. For reducing resistance maternal birth canal during childbirth.

45, nasal sprays: by the ejection system, composed of sprays, sprays and saline solution by the carrageenan composition. For the prevention and kept moist nasal mucosa, can also be used to treat nasal dryness and irritation caused by the discomfort, the treatment of colds and acute rhinitis and acute sinusitis caused by a virus.

46, non-sterile liquid filter: by the housing, the filter film. Provided non-sterile. As infusion sets, syringes, pipes and other equipment connected to the parts supply infusion equipment and other related enterprises.