| 产品名称 | 外置受话器耳背式助听器 |
|---|---|
| 结构及组成/主要组成成分 | 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/预期用途 | 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。 |
| 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). |
| 注册证编号 | 苏械注准20222190588 |
| 注册人名称 | 西万拓听力技术（苏州）有限公司 |
| 注册人住所 | 苏州工业园区苏桐路120号 |
| 生产地址 | 苏州工业园区苏桐路120号 |
| 备注 | 本文件与“苏械注准20222190588”医疗器械注册证共同使用 |
| 批准日期 | 2023-03-28 |
| 有效期至 | 2027-01-20 |
| 变更情况 | 2023-03-28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, M05, 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, 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);”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).”产品技术要求变更 由“技术要求变更情况对比表原条款及内容”变更为“技术要求变更情况对比表修改后条款及内容” |
| 编码代号2018 | 19医用康复器械 |
| 管理分类 | Ⅱ |
| 企业联系电话 | 0512-67613201 |
| 网址 | 暂无权限 |
| 临床路径 | 详情 |
| 共性问题 |
座谈会｜医疗器械共性问题答疑 说明书更改告知审查申请等共性问题解答 医疗器械产品不同批次研究资料等共性问题解答 |
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