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西万拓听力技术(苏州)有限公司

境内医疗器械(注册) — “苏械注准20222190075”基本信息
注册证编号苏械注准20222190075 [查看相关产品信息]
注册人名称西万拓听力技术(苏州)有限公司[查看公司信息]
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
产品名称耳道式助听器
管理类别第二类
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)
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。
审批部门江苏省药品监督管理局
批准日期2023/3/10
生效日期2023/3/10
有效期至2027/1/17
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