丰台总部基地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

械是具有中度风险，需要控制管理以保证其安全、有效的医疗器械。如：医用缝合针、血压计、体温计、心电图机、脑电图机、显微镜、针灸针、生化分析系统、助听器、超声消毒设备、不可吸收缝合线等。

要求：

1.商用性质办公60平，仓储40平

2.2名医学专业人员为企业负责人

3.产品经营目录

注：符合以上3点，基本上就可以办理二类医疗器械备案

提供材料

1.二类医疗器械备案申请书

2.营业执照或预先核名通知书

3.法定代表人、企业负责人、质量负责人的身份证明、学历或者职称证明复印件

4.经营场所、库房地址的地理位置图、平面图、房屋产权证明文件或者租赁协议

te risk and needs control and management to ensure its safety and effectiveness. Such as: medical suture needle, sphygmomanometer, thermometer, electrocardiogram machine, electroencephalography machine, microscope, acupuncture needle, biochemical analysis system, hearing aid, ultrasonic disinfection equipment, non-absorbable sutures, etc. ask: 1. Commercial office 60 square, storage 40 square 2.2 medical professionals are the leaders of the enterprise 3. Product management catalogue Note: If the line of the above 3 points, basically can handle the record of class II medical devices Provide materials 1. Application for filing of Class II medical devices 2. Business li