丰台丰益桥北京医疗器械二类备案医疗器械三类经营许可证放心一站式代办周期短下证快

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、实行常规管理可以保证其安全有效的医疗器械，比如手术刀、手术剪、手动病床、医用冰袋、降温贴等，其产品和生产活动由所在地设区的市级食品药品监管部门实行备案管理。经营活动则全部放开，既不用许可也不用备案，只需取得工商部门核发的营业执照即可。

02.

 machine, internal fixation e, artificial heartvalve, artificial kidney, respiratory anesthesia e,disposable sterile syringe, disposable infusion set, bloodtransfusion device, ct e, etc. how to apply for a license?01. 1, a —— need not to deal with medical device license first typeof medical e is low risk, routine management can ensure itssafe and effective medical e, such as scalpel, surgicalscissors, manual beds, medical ice packs, cooling paste, etc., itsproducts and production activities by the local district municipalfood and drug regulatory departments for the record management.business activities are all open, neither need to put on record,only need to obtain the business license issued by the industry andcommerce