耳道式助听器

国产有效注册第二类

产品名称：

耳道式助听器

注册人名称：

西万拓听力技术（苏州）有限公司

苏械注准20222190075

注册人住所：

苏州工业园区苏桐路120号

批准(备案)日期：

2023-03-10

有效期至：

2027-01-17

结构及组成：

产品由麦克风、信号处理器（放大器）、受话器、电池、各种音量音调控制旋钮，以及外壳组成。

适用范围：

用于为听力损失患者提供听力补偿，并可发生分形音调，帮助主观性耳鸣患者症状缓解。

代理公司：

代理公司地址：

变更情况：

2023-03-10型号、规格变更由“U-XP（ 30, 50, 100, 110, 220, 330, 440, 4, 4E, 6, 6E, 10, 10E, 15), U-CIC（ 30, 50, 100, 110, 220, 330, 440, 4, 4E, 6, 6E, 10, 10E, 15), U-CIC-M（ 30, 50, 100, 110, 220, 330, 440, 4, 4E, 6, 6E, 10, 10E, 15), U-CIC TR（ 30, 50, 100, 110, 220, 330, 440, 4, 4E, 6, 6E, 10, 10E, 15), U-CIC-M TR（ 30, 50, 100, 110, 220, 330, 440, 4, 4E, 6, 6E, 10, 10E, 15), U-IM（ 30, 50, 100, 110, 220, 330, 440, 4, 4E, 6, 6E, 10, 10E, 15), U-IP（ 30, 50, 100, 110, 220, 330, 440, 4, 4E, 6, 6E, 10, 10E, 15)E-XP（ 30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7), E-CIC（ 30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7), E-CIC-M（ 30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7), E-CIC TR（ 30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7), E-CIC-M TR（ 30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7), E-IM（ 30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7), E-IP（ 30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7)M-XP（110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M05, M10, M11, M22, M33, M44), M-CIC（110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M05, M10, M11, M22, M33, M44), M-CIC-M（110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M05, M10, M11, M22, M33, M44), M-CIC TR（110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M05, M10, M11, M22, M33, M44), M-CIC-M TR（110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M05, M10, M11, M22, M33, M44), M-IM（110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M05, M10, M11, M22, M33, M44), M-IP（110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M05, M10, M11, M22, M33, M44)”变更为“U-XP（ 30, 50, 100, 110, 220, 330, 440, 4, 4E, 6, 6E, 10, 10E, 15), U-CIC（ 30, 50, 100, 110, 220, 330, 440, 4, 4E, 6, 6E, 10, 10E, 15), U-CIC-M（ 30, 50, 100, 110, 220, 330, 440, 4, 4E, 6, 6E, 10, 10E, 15), U-CIC TR（ 30, 50, 100, 110, 220, 330, 440, 4, 4E, 6, 6E, 10, 10E, 15), U-CIC-M TR（ 30, 50, 100, 110, 220, 330, 440, 4, 4E, 6, 6E, 10, 10E, 15), U-IM（ 30, 50, 100, 110, 220, 330, 440, 4, 4E, 6, 6E, 10, 10E, 15), U-IP（ 30, 50, 100, 110, 220, 330, 440, 4, 4E, 6, 6E, 10, 10E, 15)E-XP（ 30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7), E-CIC（ 30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7), E-CIC-M（ 30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7), E-CIC TR（ 30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7), E-CIC-M TR（ 30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7), E-IM（ 30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7), E-IP（ 30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7)M-XP（110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M04, M05, M06, M10, M11, M22, M33, M44), M-CIC（110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M04, M05, M06, M10, M11, M22, M33, M44), M-CIC-M（110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M04, M05, M06, M10, M11, M22, M33, M44), M-CIC TR（110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M04, M05, M06, M10, M11, M22, M33, M44), M-CIC-M TR（110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M04, M05, M06, M10, M11, M22, M33, M44), M-IM（110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M05, M10, M11, M22, M33, M44), M-IP（110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M05, M10, M11, M22, M33, M44)”产品技术要求变更由“详见《变更情况对比表》“原条款及内容”列”变更为“详见《变更情况对比表》“修改后条款及内容”列”

生产地址：

苏州工业园区苏桐路120号

型号规格：

U-XP（ 30, 50, 100, 110, 220, 330, 440, 4, 4E, 6, 6E, 10, 10E, 15), U-CIC（ 30, 50, 100, 110, 220, 330, 440, 4, 4E, 6, 6E, 10, 10E, 15), U-CIC-M（ 30, 50, 100, 110, 220, 330, 440, 4, 4E, 6, 6E, 10, 10E, 15), U-CIC TR（ 30, 50, 100, 110, 220, 330, 440, 4, 4E, 6, 6E, 10, 10E, 15), U-CIC-M TR（ 30, 50, 100, 110, 220, 330, 440, 4, 4E, 6, 6E, 10, 10E, 15), U-IM（ 30, 50, 100, 110, 220, 330, 440, 4, 4E, 6, 6E, 10, 10E, 15), U-IP（ 30, 50, 100, 110, 220, 330, 440, 4, 4E, 6, 6E, 10, 10E, 15)E-XP（ 30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7), E-CIC（ 30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7), E-CIC-M（ 30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7), E-CIC TR（ 30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7), E-CIC-M TR（ 30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7), E-IM（ 30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7), E-IP（ 30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7)M-XP（110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M04, M05, M06, M10, M11, M22, M33, M44), M-CIC（110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M04, M05, M06, M10, M11, M22, M33, M44), M-CIC-M（110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M04, M05, M06, M10, M11, M22, M33, M44), M-CIC TR（110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M04, M05, M06, M10, M11, M22, M33, M44), M-CIC-M TR（110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M04, M05, M06, M10, M11, M22, M33, M44), M-IM（110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M05, M10, M11, M22, M33, M44), M-IP（110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M05, M10, M11, M22, M33, M44)

产品储存条件及有效期：

不适用

管理类别：

第二类

备注：

本文件与“苏械注准20222190075”医疗器械注册证共同使用