免于进行临床试验的第三类医疗器械目录_EN.doc

Appendix Product Catalog for Class III Medical Device Exempted from Clinical Testing No. Product Name Category Code Product Description 1 Puncture needle 6815 It is composed of the puncture needle tubing and tubing base. Seldinger technique is adopted to establish a percutaneous access for the endovascular devices. Seldinger technique is often referred to vascular puncture in digital subtraction angiography. 2 Guide sleeve 6815 It is composed of catheter and catheter base (optional). Seldinger technique is adopted to establish a percutaneous access for the endovascular devices. Seldinger technique is often referred to vascular puncture in digital subtraction angiography. 3 Disposable sterile hypodermic needle 6815 The performance, structure, composition, purpose and etc are entirely covered by GB 15811 Disposable Sterile Hypodermic Needle, the product is composed of needle base, junction, needle tubing and protection cap, it is used for intracutaneous, subcutaneous, intramuscular, intravenous injections in the human body or to draw fluid drugs. If the product contains any special function or structure (e.g. self destruction, prick proof etc), then it shall not be exempted from clinical testing. The area of exemption does not cover products that adopt new material, active ingredient, new technique, new design or products that present new purpose, mechanism or function. 4 Disposable sterilized syringe 6815 The performance, structure, composition, purpose and etc are entirely covered by the GB 15810 Disposable Sterile Syringe, the product is composed of syringe sleeve, plunger, sealing ring, core cylinder, the push end and the cone end, it is used for drawing liquid or injections by hand right after drawing liquid. If the product contains any special function or structure (e.g. self destruction, prick proof etc), then it shall not be exempted from clinical testing. The area of exemption does not cover products that adopt new material, active ingredient, ne