| 产品名称 | 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-FA(30, 50, 100, 110, 220, 330, 440, 4, 4E, 6, 6E, 10, 10E, 15); U-FP(30, 50, 100, 110, 220, 330, 440, 4, 4E, 6, 6E, 10, 10E, 15); U-FM (30, 50, 100, 110, 220, 330, 440, 4, 4E, 6, 6E, 10, 10E, 15)；E-FA(30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7); E-FM(30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7); E-FP(30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7); EBB3D (30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7)；MBB3D (30, 50, 100, 110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M04, M05, M06, M10, M11, M22, M33, M44); MBB2 (30, 50, 100, 110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M04, M05, M06, M10, M11, M22, M33, M44); MBR3D (30, 50, 100, 110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M05, M10, M11, M22, M33, M44); MBB3 (30, M1, M03, M04); ME-SP (3, 5, 10) |
| 产品储存条件及有效期 | 不适用 |
| 注册证编号 | 苏械注准20222190076 |
| 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20222190076”医疗器械注册证共同使用 |
| 批准日期 | 2023-03-28 |
| 有效期至 | 2027-01-17 |
| 变更情况 | 2023-03-28型号、规格变更 由“U-FA(30, 50, 100, 110, 220, 330, 440, 4, 4E, 6, 6E, 10, 10E, 15)，U-FP(30, 50, 100, 110, 220, 330, 440, 4, 4E, 6, 6E, 10, 10E, 15)，U-FM (30, 50, 100, 110, 220, 330, 440, 4, 4E, 6, 6E, 10, 10E, 15)；E-FA(30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7)，E-FM(30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7)，E-FP(30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7)，EBB3D (30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7)；MBB3D (30, 50, 100, 110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M05, M10, M11, M22, M33, M44），MBB2 (30, 50, 100, 110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M05, M10, M11, M22, M33, M44），MBR3D (30, 50, 100, 110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M05, M10, M11, M22, M33, M44）；MBB3 (30, M1, M03）；ME-SP (3, 5, 10）。”变更为“U-FA(30, 50, 100, 110, 220, 330, 440, 4, 4E, 6, 6E, 10, 10E, 15); U-FP(30, 50, 100, 110, 220, 330, 440, 4, 4E, 6, 6E, 10, 10E, 15); U-FM (30, 50, 100, 110, 220, 330, 440, 4, 4E, 6, 6E, 10, 10E, 15)；E-FA(30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7); E-FM(30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7); E-FP(30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7); EBB3D (30, 50, 100, 110, 220, 330, 440, E1, E2, E3, E4, E5, E6, E7)；MBB3D (30, 50, 100, 110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M04, M05, M06, M10, M11, M22, M33, M44); MBB2 (30, 50, 100, 110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M04, M05, M06, M10, M11, M22, M33, M44); MBR3D (30, 50, 100, 110, 220, 330, 440, M1, M2, M3, M4, M5, M6, M7, M03, M05, M10, M11, M22, M33, M44); MBB3 (30, M1, M03, M04); ME-SP (3, 5, 10)”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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