FDA Registration
Active
🇨🇳 China
EU1021, EU1061
Reg #: 3007694978
·
FEI: 3007694978
·
Expires 2025
Products
1
Proprietary Names
18
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- XIAMEN NEWSOUND TECHNOLOGY CO., LTD
- Registration Number
- 3007694978
- FEI Number
- 3007694978
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1st and 2nd Floor, No.13 of Xiangyue Road, Torch Hi-Tech, Industrial Development Zone, Xiang An District
- City
- Xiamen Fujian
- Country
- CN
Owner / Operator
- Firm Name
- Xiamen NewSound Technology Co., Ltd
- Operator Number
- 10028806
- Address
- 1st&2nd Floor,No.13 of XiangyueRd.,Torch, Hi-Tech Ind. Dev. Zone, XiangAn District
- City
- Xiamen
- State
- Fujian
- Postal Code
- 361001
- Country
- CN
US Agent
- Business Name
- IMHear Corporation
- Contact Name
- HONG LONDON
- Address
- 600 N Commons Dr Ste 107
- City
- Aurora
- State
- IL
- ZIP
- 60504
- Country
- US
- [email protected]
- Phone
- 630 3959628
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hearing Aid, Air-Conduction, Prescription | ESD | Class 1 | Ear, Nose, Throat | No | 2009-03-09 |
Proprietary Names
EU1021, EU1061
Ziv 209
MA41T
SAP40T
Van Pro 200, Van Pro 201, Van Pro 400, Van Pro 800
Pro 20
DX400, DX800
Asana, Asana 220, Asana Pro 200, Asana Pro 400, Asana Pro 600
EA40
Aria 200, Aria 800, Aria 810
Rocker 200, Rocker 400, Rocker 600, Rocker 800
VAN 210, VAN 401, VAN 610, VAN 810
GMS-HA17
RIE400
Vivo, Vivo 201, Vivo 202, Vivo 206, Vivo 106 FLEX, Vivo Pro 102
Van Plus 200, Van Plus 400, Van Plus 800
RV4B
CMS11H, CMS12H
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device