Fda issued a note on the de-listing of 140 medical devices (with list)

A few days ago, the China Food and Drug Administration (The National Drug Administration Medical Device Standards Management Center) released the "2020 first batch of medical device product classification definition results summary", announced 140 products not managed as medical devices.
means that these medical devices in the operation, management, transportation and many aspects of the standard, will produce qualitative changes. the results of the
related product classification are based on information provided by the applicant and do not represent an endorsement of the safety and effectiveness of the product, and are used only as a reference for the registration and filing of medical device products;
The State Drug Administration classified it according to risk as a category of two categories of three categories: One refers to the low degree of risk, the implementation of routine management can ensure its safe and effective medical devices.
is a medical device with moderate risk and needs to be strictly controlled to ensure its safety and effectiveness.
are medical devices with high risks that require special measures to be strictly controlled to ensure their safety and effectiveness.
catalog published (140) 1. Sterile sodium hyaluronic acid liquid: composed of sodium hyaluronic acid, sodium chloride, sodium dihydrophosphate, hydrogen disodium phosphate, injection water.
asteria, one-time use. Sodium hyaluronic acid contained in
products is an amino glucan and claims to be a temporary alternative to the amino glucose protective layer.
used as a temporary replacement for the lack of anopheric glucose protective layer in the bladder.
2. Medical butyl sugar (for joint cavity injection): A liquid consisting of medical butyl sugar (methyl methylethyl), sodium chloride, sodium dihydrophosphate and disodium phosphate.
the joint cavity when used as a lubricant in the bone joint.
for the prevention and treatment of trauma or degressive osteoarthritis.
3. Cross-linking methyl cellulose gastric fillers: consisting of capsules and gel particles, gel particles are pale yellow or yellow brown particles or powders, made of sodium metformin,acid, hexa-hexa-trichloride cross-linking.
used to control weight in overweight or obese adult patients.
into the stomach orally, the capsules disinteglat and release particles.
particles quickly absorb moisture to expand into dispersed gels, which have no heat, but occupy the contents of the stomach, helping to increase satiety and thus reduce food intake.
4. Injection sodium hyaluronic acid compound liquid: composed of non-cross-linked sodium hyaluronic acid, amino acids, vitamin A, vitamin B, vitamin C, vitamin E, sodium chloride, potassium chloride, magnesium sulfate, sodium acetate, sodium dihydrophosphate, calcium chloride, coenzyme A.
injected with a syringe between the skin's epidermis and dermis or in the shallow layer of the dermis, or in the skin's epidermis or in the skin's shallow layer, or between the skin's epidermis or the skin.)
Through the water lock function of sodium hyaluronic acid, it can combine its own weight of about 1000 times the moisture, quickly fill the volume of skin tissue, fill the depression wrinkles at the same time not easy to form no knots, while the increase of skin moisture can improve skin darkness.
vitamins, amino acids, trace elements and other nutrients, can effectively stimulate collagen growth, reduce wrinkles.
Vitamin C and other antioxidants can effectively remove oxygen freelance, niacin (vitamin B3) can speed up metabolism, accelerate the corneal shedding containing melanin cells, can be directly absorbed by epidermal cells, stimulate some of the aging cell vitality, promote collagen synthesis, prevent melanin over-indulgence, to achieve whitening effect.
is used for injections between the skin's epidermis and dermis or in the shallow skin to prevent or treat severe wrinkles in the middle of the skin and to improve skin darkening.
5. Particle cell removal fluid for scientific research: consisting of inorganic salt, glucose, sodium lactic acid, sodium acetone, hyaluronic acid enzyme, albumin, sulphate, and injection water.
use the oocyte mound complex is completely immersed in this product, through the product contains hyaluronic acid (i.e., the egg cell cell's extracellular matrix of the sticky polysaccharide) hexamine bond hydrolysis, by blowing, used to remove the oocyte cell from the oocyte mound complex.
for scientific purposes only.
not used (human assisted reproductive technology) clinically.
6. Absorption release with pressure-reducing non-glue plug syringe in intracogenous assisted reproductive technology: consisting of a coat and a core rod.
is provided aseptic.
for embryo transfer operation, connected with the embryo transfer catheter, by pulling the push core rod, to provide pressure to absorb the liquid containing the embryo or release the liquid in the embryo transfer catheter, to assist in the completion of the transplant operation.
not come into contact with reproductive cells, matchers, embryos, human body and other tissues and assisted reproductive fluids.
7. Vacuum connecting tubes for human assisted reproductive technology: consisting of long tubes, Ruel joints, short tubes, hydrophobic filters.
made of polymer materials and free of latex, PVC and DEHP.
is provided aseptic and used only.
used to connect the extraction needle and the negative pressure vacuum pump, providing a pathway in a negative pressure environment to draw the egg from the attractor tube into the egg-picking tube.
do not come into contact with reproductive cells, matchmakers, embryos, human stakes and other tissues and auxiliary reproductive fluids.
8. Home ovulation test mirror: a small microscope consisting of a protective case, lens assembly, and battery assembly with a zoom-in lens.
used to provide a time period for the age-appropriate women who are preparing to conceive. When
use, the image of the user's dry saliva is observed under a microscope, when the estrogen level increases, it can promote the increase of the salt content of saliva, and the crystallization pattern formed by the increase of salt level swell level is compared with the pattern formed when the salt level is low, which shows the link between the salt content level of estrogen and saliva.
provides a reference-only ovulation time by comparing images of dry saliva monitored daily with 2000 images provided in the instructions.
9. Sample absorption or discharge tool for assisted reproduction: consisting of plunger wire, syringe, chuck, thumb holder and bracket.
made of stainless steel.
non-sterile and can be reused.
is used in matching medical peeling straws with plastic.
is used to absorb or expel samples in assisted reproductive techniques through the pressure differential principle.
use, do not directly contact with assisted reproductive fluids and embryos, eggs, sperm and other tissues.
10. Lactose vaginal tablets: made from a water lactose, magnesium stearate and silicon dioxide.
mainly by regulating the pH of the vaginal environment, to assist in the treatment of bacterial vaginitis, reduce unpleasant vaginal odors and excreta, relieve vaginal dryness, itching, irritation and pain symptoms.
11. Household vaginal rinser: consisting of a conveyor pipe, pressure-relief sheet, battery, control plate, motor, gear, sealring, silicone keys, bearings, rotating silicone nozzles.
do not contain medication, no washing liquid.
non-sterile and reusable.
access to drinking water when using, the rotating silicone nozzle is inserted into the vagina for husband and wife after the room vaginal semen flushing and women's daily vaginal hygiene cleaning.
12. Oral equipment pre-grinding kit: consisting of grinding stones and test rods.
test rods are round rod-shaped products made of glass resin, and grinding stones are round, rectangular and deformed products made of stainless steel.
is used to sharpen and pre-grind blunt oral instruments to make them sharp, and test rods are used to test the cutting effect of devices such as scrapers and spoons.
13. Implant processing UV irradiator: by the machine housing, UV lamp, airbag (with fault feedback), active warehouse components, display, photoelectric switches and control circuits, power modules and so on.
by producing ultraviolet radiation, it causes the surface photocification of titanium dioxide, which produces titanium dioxide, breaks down organic matter and produces super-hydrophotogenic surfaces.
can delay the recovery of titanium surface aging due to time factors, improve the bioactivity of titanium surface, so that the surface of the implant has super-hydrogenic, in order to improve bone binding rate.
14. Implant processing UV irradiation instrument: consisting of control panel, ultraviolet lamp, motherboard, UV irradiated reflector.
claims to have placed the finished implant (the implant packaging unopened) in the product in the hospital, causing the implant (including the implant, which has been coated, sandblasting, acid-absorbed titanium) to be photocated on the surface of the implant (including the titanium material coated by the surface, blasted, acid-absorbed) into the product, creating an ultra-hydrophilic surface.
can delay and restore the aging phenomenon of titanium surface caused by time factors, improve the bioactivity of titanium surface of the implant, and make the surface of the implant super hydrophilic, in order to improve bone binding rate.
15. Light-curing lamps: active devices consisting of hosts, resin storage boxes, displays, glass soles, handles and power adapters.
used to cure the resin by exposing it to ultraviolet light to produce a polymerization reaction.
light-cured resins made by the company are used in the preparation of dental models, dental guides or pallets.
16. Composite resin heaters for oral filling repair: consisting of cylindrical placers (e.g. resin tubes, vials, bullets), electronic control switches, LED indicators, temperature selection switches and power supplies.
for dental repair, the oral filling repair resin is placed in a resin tube, vial or bullet head for heating, and then the heated resin is used for direct or indirect repair of the teeth.
17. Composite resin heater for oral filling repair: consists of a thermostat heater, tray and filter blue cover.
is used to heat the compound resin for oral filling repair.
When using, the composite resin is extruded into the thermostat groove to cover the filter cover to prevent the resin from curing, set the temperature for heating, or place the entire composite resin in the tray heating hole, set the temperature for heating, and then use the heated resin for tooth filling.
18. Antibacterial braces: braces made of ethylene-acetate co-polys, silver and zinc inorganic antibacterial agents molded and suppressed.
worn on the tooth, the antibacterial agent in the brace inhibits the bacteria on the surface of the tooth, and is used to inhibit the bacteria on the surface of the tooth in the mouth.
19. Teeth Whitening Pen: consists ofteeth whitening gel and its tyrosing container.
, tooth whitening gel consists of ethanol, polyethylene pyrequinone, water, silica, hydrogen peroxide (less than or equal to 3.0%), polyethyl glycol-400, sodium saccharin, edible flavor (material), sodium phosphate, sodium citrate, phosphoric acid, trisodium phosphate, sodium chloride;
not used with dental cold whitening instruments.
squeeze out the teeth when used to whiten the gel thinly applied to the teeth and remove it after 1 hour by gargling or brushing.
spread through hydrogen peroxide to tooth enamel and tooth essence, oxidizing organic and inorganic colored compounds (pigments) for whitening teeth.
20. Teeth whitening glue: a gel consisting of water, glycerin, hydrogen peroxide (2.1 to 3.0%), capom, citric acid, sodium fluoride, potassium nitrate and spices.
is not used with dental cold-light whitening instruments.
When using, place in the tooth support (the tooth support is passive product, does not have the function of emitting cold light to assist whitening) and then place the brace in the inlet, gently bite for 15 to 30 minutes;
the oxygen atoms released by hydrogen peroxide in the product have a chemical effect on the surface pigment of the teeth to remove tooth stains, which can be used to whiten teeth and remove tooth stains in healthy people over 16 years of age.
21. Tooth protector: composed of water, glycerin, sodium citrate, cyclomycin glucosamine, spices, citric acid, sucralose, sodium benzoate, hydroxyethyl cellulose, etc.
claims that through the content of the pyrogenic methyl glucosamine anti-dental plaque surface active agent, can reduce surface tension, so that the product adheres to the surface of the teeth, the formation of a so-called liquid membrane, this layer of liquid membrane can reduce the attachment of plaque, thereby preventing the accumulation of plaque, prevent and reduce plaque and gingivitis, including gum swelling and bleeding.
cannot prove that the ingredients contained do not play a pharmacological role (e.g. sodium benzoate has a certain antibacterial effect, can not prove that it has no effect on the prevention of gingivitis).
22. Clean floss: A elastic plush wire with a lead, including plush wire and lead, one end of the lead and one end of the plush wire.
plush line structure is rough and fluffy, surface hole, has a certain elasticity.
made of polymer materials.
non-sterile, one-time use.
for daily periodontal and oral cleaning care for implanted teeth/body, bridge, orthodontic and wide teeth. When
use, the lead can pass through the tooth seams, tooth bridges, orthodontic steel wire, wide tooth seams, the back end of the connection of elastic plush wire can be pushed and pulled by the plush wire, the surface of the rough opening can be adsorbed to the teeth, such as the accumulation of food particles, fragments and patches, so as to clean the corresponding gap in the teeth.
23. Dentures, orthopaedics, bite board cleaning machine: by the host, disinfectable cleaning cup, cleaning liquid plastic container, fixed magnet, tweezers, power cord composition.
does not contain cleaning needles or cleaning fluids.
for oral science and technology workshop cleaning can pick local dentures, orthopaedic devices, bite plate. When
use, put the cleaning pin, cleaning fluid and the dentures (or an orthot, bite plate) into the cleaning cup, close the lid and insert the cup into the machine, start the cleaning machine, during the cleaning machine rotation, the cleaning needle and denture (or the ortifier, bite plate) rub each other, the dentures (or the ortifier, bite plate) on the stones, stains clean.
24. In vitro cleaners for pre-treated ceramics, zirconium oxides and metal repairs: consisting of deionized water, potassium hydroxide, jaundice and thorium blue sodium salts.
non-sterile.
is used in dental workshops only for use in dental workshops for pre-treated ceramics, zirconia oxides and metal repairs contaminated by saliva during oral cleaning outside the mouth through hydrolysis and dissolution of potassium hydroxide.
25. Oral Science and Technology Workshop with Dressing Polish Tool Set: includes guide bar, 45-degree shoulder trimmer and handle.
made of metal.
is only available.