FDA Registration
Active
🇨🇳 China
MAT4
Reg #: 3007694978
·
FEI: 3007694978
·
Expires 2025
Products
1
Proprietary Names
19
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, Over The Counter | QUF | Class 1 | Ear, Nose, Throat | No | 2022-11-01 |
Proprietary Names
MAT4
PURE series
Helix
Poco M201, Poco M401
Encore
Poco Z101, Poco Z401
Poco Q101
Rocker 202, Rocker 402
BEE III 101
TactEar 801
Primo M401, Primo R401, Primo S401
Whisper
B10
GMS-HA23
Smart 401
EA4
EX2
EasyCharge, EasyCharge Pro
DX4, DX8
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device