外置受话器耳背式助听器-苏械注准20222190588-器械数据

产品名称：

外置受话器耳背式助听器

注册人名称：

西万拓听力技术（苏州）有限公司

注册(备案)号：

苏械注准20222190588

注册人住所：

苏州工业园区苏桐路120号

批准(备案)日期：

2024-10-16

有效期至：

2027-01-20

结构及组成：

产品由麦克风、数字处理器、受话器、编程接口、存储器组成；零配件有耳模或耳塞、导线和导声管；电源为锌空电池(包括可充电电池)；附件包括充电套件。

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：

2024-10-16型号、规格变更由“U-FS (30, 50, 100, 110, 220, 330, 440, 4, 4E, 6, 6E, 10, 10E, 15)／(规格：S, M, P, HP);U-PA (30, 50, 100, 110, 220, 330, 440, 4, 4E, 6, 6E, 10, 10E, 15)／(规格：S, M);E-FS (30, 50, 100, 110, 220, 330, 440, E1 E2, E3, E4, E5, E6, E7)／(规格：S, M, P, HP);E-F2 (30, 50, 100, 110, 220, 330, 440, E1 E2, E3, E4, E5, E6, E7)／(规格：S, M, P, HP);E-PA (30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7)／(规格：S, M);ERB0 (30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7)／(规格：S, M);ERB2D (30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7)／(规格：S, M, P, HP);MRB0 (30, 50, 100, 110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M04, M05, M06, M10, M11, M22, M33, M44)／(规格：S, M);MRB2D (30, 50, 100, 110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M05, M06, M10, M11, M22, M33, M44)／(规格：S, M, P, HP);MRR2D (30, 50, 100, 110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M05, M10, M11, M22, M33, M44)／(规格：M, P);MRR4D (30, 50, 100, 110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M05, M10, M11, M22, M33, M44)/ (规格：M, P).”变更为“U-FS (30, 50, 100, 110, 220, 330, 440, 4, 4E, 6, 6E, 10, 10E, 15)／(规格：S, M, P, HP);U-PA (30, 50, 100, 110, 220, 330, 440, 4, 4E, 6, 6E, 10, 10E, 15)／(规格：S, M);E-FS (30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7)／(规格：S, M, P, HP);E-F2 (30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7)／(规格：S, M, P, HP);E-PA (30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7)／(规格：S, M);ERB0 (30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7)／(规格：S, M);ERB2D (30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7)／(规格：S, M, P, HP);MRB0 (30, 50, 100, 110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M04, M05, M06, M10, M11, M22, M33, M44)／(规格：S, M);MRB2D (30, 50, 100, 110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M05, M06, M10, M11, M22, M33, M44)／(规格：S, M, P, HP);MRR2D (30, 50, 100, 110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M05, M10, M11, M22, M33, M44)／(规格：M, P);MRR4D (30, 50, 100, 110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M05, M10, M11, M22, M33, M44)/ (规格：M, P, HP)MRRLD (30, 50, 100, 110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M05, M10, M11, M22, M33, M44)／(规格：M, P)”产品技术要求变更由“变更情况对比表中原条款及内容”变更为“变更情况对比表中修改后条款及内容”

生产地址：

苏州工业园区苏桐路120号

型号规格：

U-FS (30, 50, 100, 110, 220, 330, 440, 4, 4E, 6, 6E, 10, 10E, 15)／(规格：S, M, P, HP);U-PA (30, 50, 100, 110, 220, 330, 440, 4, 4E, 6, 6E, 10, 10E, 15)／(规格：S, M);E-FS (30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7)／(规格：S, M, P, HP);E-F2 (30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7)／(规格：S, M, P, HP);E-PA (30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7)／(规格：S, M);ERB0 (30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7)／(规格：S, M);ERB2D (30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7)／(规格：S, M, P, HP);MRB0 (30, 50, 100, 110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M04, M05, M06, M10, M11, M22, M33, M44)／(规格：S, M);MRB2D (30, 50, 100, 110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M05, M06, M10, M11, M22, M33, M44)／(规格：S, M, P, HP);MRR2D (30, 50, 100, 110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M05, M10, M11, M22, M33, M44)／(规格：M, P);MRR4D (30, 50, 100, 110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M05, M10, M11, M22, M33, M44)/ (规格：M, P, HP)MRRLD (30, 50, 100, 110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M05, M10, M11, M22, M33, M44)／(规格：M, P)

产品储存条件及有效期：

不适用

管理类别：

Ⅱ

备注：

本文件与“苏械注准20222190588”医疗器械注册证共同使用