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2009
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08
Catalogue of National Key Regulatory Medical Devices (2009 Edition)
1. single-use sterile medical devices
1. Sterile syringes for single use;
2. Disposable infusion set;
3. Single-use blood transfusion device;
4. Single-use burette infusion set;
5. Disposable intravenous infusion needle;
6. Sterile injection needle for single use;
7. disposable plastic blood bag;
8. Single-use blood collection device;
9. Disposable anesthesia puncture kit;
10. Medical suture needle (thread).
2. Orthopaedic Implants Medical Devices
1. Surgical implants, joint prostheses;
2. Metal straight and special-shaped bone plates;
3. Metal boning and orthopedic nails;
4. Metal orthopedic rods;
5. Intramedullary needle, bone needle;
6. Spinal internal fixation equipment.
3. implantable medical devices
1. Intraocular lens;
2. Artificial heart valves;
3. Cardiac pacemaker;
4. Endovascular stent, catheter, guide wire, balloon.
4. filling material
1. Breast filling material;
2. Intraocular filling materials;
3. Orthopedic filling materials.
5. allogeneic medical devices
1. Allogeneic bone;
2. Allogeneic skin;
3. Biological amniotic membrane.
6. medical devices of animal origin
1. Artificial biological heart valve;
2. Biological protein sponge;
3. Biofilm;
4. Xenogeneic bone repair materials;
5. Biological dressings;
6. Tissue-engineered full-thickness skin;
7. Bioadhesive.
7. medical devices for family planning
1. Intrauterine device;
2. Rubber condoms.
8. extracorporeal circulation and blood treatment medical devices
1. Hollow fiber dialyzer;
2. Hemodialysis device;
3. Dialysis powder, dialysis fluid;
4. Plasma separation cup, plasma pipeline.
Anti-adhesion medical devices for 9. surgery
10. orthokeratology lens
XI. Infant Incubator
XII. Medical protective masks and medical protective clothing
