| 产品名称 | 耳道式助听器 |
|---|---|
| 结构及组成/主要组成成分 | 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/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-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 |
| 注册证编号 | 苏械注准20222190075 |
| 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20222190075”医疗器械注册证共同使用 |
| 批准日期 | 2023-03-10 |
| 有效期至 | 2027-01-17 |
| 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” |
| 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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