| 办证机构： | 长沙市药监局 |
| 分类编号： | 09-01-05 |
| 管理类别： | 第一类 |
| 产品名称： | 理疗电极片 |
| 型号规格： | ZC-LK01φ30mm ZC-LX01φ30mm ZC-LT01φ30mm ZC-LK02φ40mm ZC-LX02φ40mmZC-LT02φ40mm ZC-LK03φ50mm ZC-LX03φ50mm ZC-LT03φ50mm ZC-LK04φ60mmZC-LX04φ60mm ZC-LT04φ60mm ZC-LK05φ70mm ZC-LX05φ70mm ZC-LT05φ70mmZC-LK06φ80mm ZC-LX06φ80mm ZC-LT06φ80mm ZC-LK07φ85mm ZC-LX07φ85mmZC-LT07φ85mm ZC-LK07φ90mm ZC-LX07φ90mm ZC-LT07φ90mm ZC-LK08φ95mmZC-LX08φ95mm ZC-LT08φ95mm ZC-LK09φ100mm ZC-LX09φ100mmZC-LT09φ100mmZC-LK10φ120mm ZC-LX10φ120mm ZC-LT10φ120mm ZC-LK1150X50mm ZC-LX1150X50mmZC-LT1150X50mm ZC-LK1260X60mmZC-LX1260X60mmZC-LT1260X60mmZC-LK1370X70mmZC-LX1370X70mmZC-LT1370X70mmZC-LK1475X75mmZC-LX1475X75mmZC-LT1475X75mmZC-LK1575X80mmZC-LX1575X80mmZC-LT1575X80mmZC-LK1680X80mmZC-LX1680X80mmZC-LT1680X80mmZC-LK1780X85mmZC-LX1780X85mmZC-LT1780X85mmZC-LK1885X85mmZC-LX1885X85mmZC-LT1885X85mmZC-LK1985X90mmZC-LX1985X90mmZC-LT1985X90mmZC-LK2090X90mmZC-LX2090X90mmZC-LT2090X90mmZC-LK2190X95mmZC-LX2190X95mmZC-LT2190X95mmZC-LK2295X95mmZC-LX2295X95mmZC-LT2295X95mmZC-LK2395X100mmZC-LX2395X100mmZC-LT2395X100mmZC-LK24100X100mmZC-LX24100X100mmZC-LT24100X100mmZC-LK25110X110mmZC-LX25110X110mmZC-LT25110X110mmZC-LK26120X120mmZC-LX26120X120mmZC-LT26120X120mmZC-LK2760X100mmZC-LX2760X100mmZC-LT2760X100mmZC-LK2870X100mmZC-LX2870X100mmZC-LT2870X100mmZC-LK2970X120mmZC-LX2970X120mmZC-LT2970X120mmZC-LK3080X120mmZC-LX3080X120mmZC-LT3080X120mmZC-LK3180X130mmZC-LX3180X130mmZC-LT3180X130mmZC-LK3290X130mmZC-LX3290X130mmZC-LT3290X130mmZC-LK33100X150mmZC-LX33100X150mmZC-LT33100X150mmZC-LK3487X51mmZC-LX3487X51mmZC-LT3487X51mmZC-LK3564X98mmZC-LX3564X98mmZC-LT3564X98mmZC-LK3626X26mmZC-LX3626X26mmZC-LT3626X26mmZC-LK3730X30mmZC-LX3730X30mmZC-LT3730X30mmZC-LK3840X40mmZC-LX3840X40mmZC-LT3840X40mmZC-LK3960X100mmZC-LX3960X100mmZC-LT3960X100mmZC-LK4064X138mmZC-LK4085X170mmZC-LX4085X170mmZC-LT4185X170mmZC-LK41160X160mmZC-LX41160X160mmZC-LT42160X160mmZC-LK4225X42mmZC-LX4225X42mmZC-LT4325X42mmZC-LK4345X71mmZC-LX4345X71mmZC-LT4445X71mmZC-LK4430X60mmZC-LX4430X60mmZC-LT4530X60mmZC-LK4560X90mmZC-LX4560X90mmZC-LT4660X90mmZC-LK4670X150mmZC-LX4670X150mmZC-LT4770X150mmZC-LK4740X60mmZC-LX4740X60mmZC-LT4840X60mm |
| 结构及组成/主要组成成分： | 由导电材料及硅胶组成。 |
| 适用范围/预期用途： | 使用时，贴附在理疗部位。配合中低频、干扰电等电疗设备，将电疗设备输出的电刺激信号传导到人体皮肤表面。 |
1、注册申报（注册发补）。
2、设计开发资料。
3、工厂GMP质量管理体系编撰及培训。
4、辅导批记录。
5、辅助现场核查及取得生产许可证。
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