洗耳球、陰道洗滌器、氣墊、肛門袋，圈、集尿袋、引流袋等；

2二類醫療器械

如體溫計、血壓計、助昕器、制氧機、避孕套、針灸針、心電診斷儀器、無創監護儀器、光學內窺鏡、便攜式超聲診斷儀、全自動生化分析儀、恒溫培養箱、牙科綜合治療儀、醫用脫脂棉、醫用脫脂紗布等；

3三類醫療器械

如植入式心臟起搏器、體外震波碎石機、病人有創監護系統、人工晶體、有創內窺鏡、超聲手術刀、彩色超聲成像設備、激光手術設備、高頻電刀、微波治療儀、醫用核磁共振成像設備、X線治療設備、醫用高能設備、人工心肺機、內固定器材、人工心臟瓣膜、人工腎、呼吸麻醉設備、一次性使用無菌注射器、一次性使用輸液器、輸血器、CT設備等。

怎樣辦理許可證？

01.

1、一類——不用辦理醫療器械許可證 第一類醫療器械是風險程度低、實行常規管理可以保證其安全有效的醫療器械，比如手術刀、手術剪、手動病床、醫用

ve endoscope, ultrasonic scalpel, color ultrasound imaging e, laser surgery e, high frequency electric knife, microwave treatment instrument, medical nuclear magnetic resonance imaging e, X-ray treatment e, medical high-energy e, artificial cardiopulmonary machine, internal fixation e, artificial heart valve, artificial kidney, respiratory anesthesia e, disposable sterile syringe, disposable infusion set, blood transfusion device, CT e, etc. How to apply for a license? 01. 1. Class I —— No applying for medical device license Class I medical devices are low risk and routine management can ensure their safe and effective medical instruments, such as scalpel, sur