FDA Registration
Active
🇨🇳 China
Wireless Bluetooth Hearing Aid
Reg #: 3038319748
·
FEI: 3038319748
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- SHENZHEN LARK ACOUSTICS CO., LTD.
- Registration Number
- 3038319748
- FEI Number
- 3038319748
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 502, Sanhang Science and Technology Building, Northwestern Polytechnical University, 45 Gaoxin Nanjiu Road, High-tech Zone Community, Yuehai Street, Nanshan District
- City
- Shenzhen Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- ShenZhen Lark Acoustics Co., Ltd.
- Operator Number
- 10093370
- Address
- 502, Sanhang Science and Technology Building, Northwestern Polytechnical University, 45 Gaoxin Nanjiu Road, High-tech Zone Community, Yuehai Street, Nanshan District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 51800
- Country
- CN
- Correspondent
- Tammy Tan
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | Class 2 | Ear, Nose, Throat | No | 2025-05-07 |
Proprietary Names
Wireless Bluetooth Hearing Aid
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)