FDA Registration
Active
🇨🇳 China
T016 T017 T018 T019 T020 T021 T022 T023 T024 T025 T026 T027 T028 T029 T030
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, Prescription | OSM | Class 2 | Ear, Nose, Throat | No | 2022-11-13 |
Proprietary Names
T016 T017 T018 T019 T020 T021 T022 T023 T024 T025 T026 T027 T028 T029 T030
Wireless Bluetooth Hearing Aid/Amplifier T001 T002 T003 T004 T005 T006 T007 T008 T009 T010 T011 T012 T013 T014 T015
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device