西城马甸北京医疗器械二类备案医疗器械三类经营许可证专业办理经验丰富靠谱Zui快7天下证

镜、超声手术刀、彩色超声成像设备、激光手术设备、高频电刀、微波缓解仪、医用核磁共振成像设备、X线缓解设备、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等。

三类申请医疗器械经营许可证条件：

1.具有与经营规模和经营范围相适应的质量管理机构或者专职质量管理人员。质量管理人员应当具有国家认可的相关专业学历或者职称；

2.具有与经营规模和经营范围相适应的相对独立的经营场所；

3.具有与经营规模和经营范围相适应的储存条件，包括具有符合医疗器械产品特性要求的储存设施、设备；

, ultrasonic scalpel, color ultrasound imaging equipment, lasersurgery equipment, high frequency electric knife, microwave reliefinstrument, medical nuclear magnetic resonance imaging equipment,X-ray relief equipment, medical high-energy equipment, artificialheart and lung machine, internal fixation equipment, artificialheart valve, artificial kidney, respiratory anesthesia equipment,disposable sterile syringe, disposable infusion set, bloodtransfusion device, CT, etc. Conditions for applying for theMedical Device Business License: 1. It shall have a qualitymanagement institution or full-time quality management personnelsuitable for the business scale and business scope. The qualitymanagement personnel shall have the relevant professional academicqualifications or professional titles