A category,Category II,三类医疗器械分类有哪些？

A category,Category II,三类医疗器械分类有哪些？ 国家对于医疗器械有着严格的分类：A category,Category II,Category three，而三类 医疗器械 是最高级别的医疗器械，也是必须严格控制的医疗器械，refers to implantation into the human body，for support、sustain life，Potentially dangerous to human body，to its security、Medical devices whose effectiveness must be strictly controlled。

下面一起了解一下吧 第一类医疗器械有：Basic surgical knives "Scalpel handle and blade、Skin grafting knife、wart peeling knife、lancet、Blade、razor、dandruff scraper、Pick a knife、sharp knife、Shukyakuto、manicure knife、解剖刀等》 第二类医疗器械：(a)General diagnostic equipment(6820)：thermometer、sphygmomanometer;( b)Physical therapy and rehabilitation equipment(6826)：Magnetic therapy equipment; (c)Clinical testing and analysis instruments(6840)：Home-use blood glucose analyzer and test strips; (d)operating room、emergency room、Clinic equipment and appliances(6854)：Medical small oxygen concentrator portable oxygen generator; (e)Medical hygiene materials and dressings(6864)：Use absorbent cotton、Medical skim gauze; (f)Medical polymer materials and products(6866)：condom、避孕帽等 第三类医疗器械：A、Disposable sterile medical devices

1. Disposable sterile syringe;
2. Disposable infusion set;
3. Disposable blood transfusion set;
4. Disposable anesthesia puncture kit;
5. Disposable intravenous infusion needle;
6. Disposable sterile injection needle;
7. Disposable plastic blood bags;
8. Disposable blood collection device;
9. Disposable burette infusion set。

B、Orthopedic Implants Medical Devices

1. surgical implant joint prosthesis;(Disposable sterile medical devices、hearing aid、Contact lenses and care solutions、In vitro diagnostic reagents、6846Implant materials and artificial organs、6877Except for interventional devices)等 办理二类医疗器械需要什么材料
2. 提供所经营产品的备案号与产品种类；
3. 提供一名医疗相关人员的相关职业毕业证书与身份证复印件；
4. 提供公司营业执照副本原件；
5. 提供公司公章；
6. 提供公司的规章制度及管理手册；
7. 提供一个仓储地址的房屋租赁合同、Copy of real estate certificate、Copy of landlord’s ID card；
8. 提供仓储地址的房屋布局图；

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