FDA Registration
Active
🇨🇳 China
Hearing Aid, Amplifiers With Models H001 H002 H003 H004 H005 H006 H007 H008 H009 H010 H011 H012 H013 H014 H015 H016
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, Prescription | ESD | Class 1 | Ear, Nose, Throat | No | 2023-02-16 |
Proprietary Names
Hearing Aid, Amplifiers With Models H001 H002 H003 H004 H005 H006 H007 H008 H009 H010 H011 H012 H013 H014 H015 H016
H017 H018 H019 H020 H021 H022 H023 H024 H025 H026 H027 H028 H029 H030
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