FDA Registration
Active
🇨🇳 China
Hearing Aid, Amplifiers With Models G001 G002 G003 G004 G005 G006 G007 G008 G009 G010 G011 G012 G013 G014 G015 G016 G017
Reg #: 3025427079
·
FEI: 3025427079
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
4
Classifications
1
Registration Details
- Registration Name
- SHENZHEN TONYCORE TECHNOLOGY CO.,LTD.
- Registration Number
- 3025427079
- FEI Number
- 3025427079
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Room 808, Xinlong Building, Minzhi Street, Longhua District
- City
- Shenzhen Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- Shenzhen TonyCore Technology Co.,Ltd.
- Operator Number
- 10086486
- Address
- Room 808, Xinlong Building, Minzhi Street, Longhua District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518131
- Country
- CN
- Correspondent
- JiaChuan Lin
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, Over The Counter | QUG | Class 2 | Ear, Nose, Throat | No | 2023-01-15 |
Proprietary Names
Hearing Aid, Amplifiers With Models G001 G002 G003 G004 G005 G006 G007 G008 G009 G010 G011 G012 G013 G014 G015 G016 G017
G018 G019 G020 G021 G022 G023 G024 G025 G026 G027 G028 G029 G030
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device