2二类医疗器械
如体温计、血压计、助昕器、制氧机、避孕套、针灸针、心电诊断仪器、无创监护仪器、光学内窥镜、便携式超声诊断仪、全自动生化分析仪、恒温培养箱、牙科综合治疗仪、医用脱脂棉、医用脱脂纱布等;
3三类医疗器械
如植入式心脏起搏器、体外震波碎石机、病人有创监护系统、人工晶体、有创内窥镜、超声手术刀、彩色超声成像设备、激光手术设备、高频电刀、微波治疗仪、医用核磁共振成像设备、X线治疗设备、医用高能设备、人工心肺机、内固定器材、人工心脏瓣膜、人工肾、呼吸麻醉设备、一次性使用无菌注射器、一次性使用输液器、输血器、CT设备等。
怎样办理许可证?
01.
1、一类——不用办理医疗器械许可证 第一类医疗器械是风险程度低、实行常
t, high frequency electric knife, microwave treatment instrument, medical nuclear magnetic resonance imaging equipment, X-ray treatment equipment, medical high-energy equipment, artificial cardiopulmonary machine, internal fixation equipment, artificial heart valve, artificial kidney, respiratory anesthesia equipment, disposable sterile syringe, disposable infusion set, blood transfusion device, CT equipment, etc. How to apply for a license? 01. 1. Class I —— does not need to apply for a medical device license, while Class I medical device has a low risk degree and a frequent implementation