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南昌华安众辉健康科技有限公司

境内医疗器械(注册) — “赣械注准20152010075”基本信息
注册证编号赣械注准20152010075 [查看相关产品信息]
注册人名称南昌华安众辉健康科技有限公司[查看公司信息]
注册人住所江西省南昌市南昌高新技术产业开发区创新一路59号5号楼
生产地址江西省南昌市南昌高新技术产业开发区创新一路59号5号楼
产品名称中性电极(负极板)
管理类别第二类
型号规格GBS-1030ac、GBS-1000ac、GBS-1010ac、GBS-1020ac、GBS-1030bc、GBS-1030a、GBS-1000a、GBS-1010a、GBS-1020a、GBS-1030b、GBS-1031ac、GBS-1001ac、GBS-1011ac、GBS-1021ac、GBS-1031bc、GBS-1031a、GBS-1001a、GBS-1011a、GBS-1021a、GBS-1031b、GBS-1040ac、GBS-1050ac、GBS-1060ac、GBS-1070ac、GBS-1040bc、GBS-1040a、GBS-1050a、GBS-1060a、GBS-1070a、GBS-1040b、GBS-1041ac、GBS-1051ac、GBS-1061ac、GBS-1071ac、GBS-1041bc、GBS-1041a、GBS-1051a、GBS-1061a、GBS-1071a、GBS-1041b、GBS-1130ac、GBS-1100ac、GBS-1110ac、GBS-1120ac、GBS-1130bc、GBS-1130a、GBS-1100a、GBS-1110a、GBS-1120a、GBS-1130b、GBS-1131ac、GBS-1101ac、GBS-1111ac、GBS-1121ac、GBS-1131bc、GBS-1131a、GBS-1101a、GBS-1111a、GBS-1121a、GBS-1131b、GBS-1140ac、GBS-1150ac、GBS-1160ac、GBS-1170ac、GBS-1140bc、GBS-1140a、GBS-1150a、GBS-1160a、GBS-1170a、GBS-1140b、GBS-1141ac、GBS-1151ac、GBS-1161ac、GBS-1171ac、GBS-1141bc、GBS-1141a、GBS-1151a、GBS-1161a、GBS-1171a、GBS-1141b、GBS-2030、GBS-2031、GBS-2130、GBS-2131、GBS-3030、GBS-3031、GBS-3130、GBS-3131
结构及组成/主要组成成分本产品由隔离层、背衬、铝箔、导线组成。
适用范围/预期用途在高频电刀设备中用作与患者身体连接的电极。在高频电外科手术的单极电切/电凝中提供高频电流回路作用。单极电极可供普通高频电刀设备配套使用,双极电极可供配有报警系统的高频电刀设备配套使用。
审批部门江西省药品监督管理局
批准日期2020/8/10
生效日期2020/8/10
有效期至2025/8/9
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