FDA Registration
Active
🇨🇳 China
Groove
Reg #: 3007694978
·
FEI: 3007694978
·
Expires 2025
Products
1
Proprietary Names
9
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 With Wireless Technology, Over The Counter | QUG | Class 2 | Ear, Nose, Throat | No | 2022-11-01 |
Proprietary Names
Groove
BW21, BW51, BW52, BW53
Sona
Tweak Enhance
Sigma Plus
Primo MA401, Primo SA401, Primo DA801
HioNec FIT
Poco MU803
LIVE series
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device