术刀柄和刀片、普通止血钳、子弹钳、纱布剥离钳、海绵钳、帕巾钳、皮管钳、器械钳、显微耳针、显微喉针、显微耳钩、显微喉钩、显微枪形麦粒钳、显微喉钳、显微持针钳、角膜镊、眼用镊、眼用结扎镊、纱布绷带、弹力绷带、石膏绷带、创口贴、手术衣、手术帽、口罩、手术垫单、手术洞巾、检查手套,指套、洗耳球、阴道洗涤器、气垫、肛门袋,圈、集尿袋、引流袋等;3三类医疗器械二类——市药监局办理医疗器械经营备案第二类医疗器械是具有中度风险,需要严格控制管理以保证其安全有效的医疗器械,比如我们日常生活中常见的创可有什么要求呢?徐冰为您详细介绍:一、公司增加一类医疗器械经营范围第一类医疗器械是指,通过常规管理足以保证其安全性、有效性的医疗器械。一类医疗许可证无需办理经营许可证。如果是生产医疗器械,则需要到相关部门备案。二、公司增加二类医疗器械经营范围二类医疗器械备案要求,根据《医疗器械监督管理条例》凡是从事二类医疗器械经营的单位都需要到所在地设区的市级食品药品监督管理部门备案,二类医疗器械是具有中度风险,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。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
gauze stripping forceps, sponge forceps, forceps, skin forceps,instrument forceps, microscopic ear needle, microscopic laryngealneedle, microscopic ear hook, microscopic throat hook, micro gun,forceps, forceps, microscopic needle forceps, corneal forceps,forceps, eye forceps, eye ligation forceps, gauze bandage, elasticbandage, plaster bandage, band-aid, surgical clothing, surgicalcap, surgical masks, single, surgical pad, surgical tissue,inspection gloves, Fsleeve, ear wash, vaginal washer, air cushion,anal pouch, Circle, urine collection bag, drainage bag, etc.; 3Class III medical devices Class II —— Municipal Food and DrugAdministration for medical device business record Class II medicaldevices have moderate risk, Need for strict control and managementto ensure their safe and effective medical devices, For example,what are the common requirements of innovation in our daily life?Class I medical devices refer to the medical devices that aresufficient to ensure their safety and effectiveness through routinemanagement. A Class I medical license do