FDA Registration
Active
🇨🇳 China
SHENZHEN TONYCORE TECHNOLOGY CO.,LTD.
Reg #: 3025427079
·
FEI: 3025427079
·
Expires 2026
Products
4
Proprietary Names
8
Establishment Types
4
Classifications
4
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Registration Details
- Registration Name
- SHENZHEN TONYCORE TECHNOLOGY CO.,LTD.
- Registration Number
- 3025427079
- FEI Number
- 3025427079
- Status
- Active
- Expiry Year
- 2026
- 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 |
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | Class 2 | Ear, Nose, Throat | No | 2022-11-13 |
| Hearing Aid, Air-Conduction, Prescription | ESD | Class 1 | Ear, Nose, Throat | No | 2023-02-16 |
| Hearing Aid, Air-Conduction, Over The Counter | QUF | Class 1 | 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
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
H017 H018 H019 H020 H021 H022 H023 H024 H025 H026 H027 H028 H029 H030
Hearing Aid, Amplifiers With Models H001 H002 H003 H004 H005 H006 H007 H008 H009 H010 H011 H012 H013 H014 H015 H016
D017 D018 D019 D020 D021 D022 D023 D024 D025 D026 D027 D028 D029 D030
Hearing Aid, Amplifiers With Models D001 D002 D003 D004 D005 D006 D007 D008 D009 D010 D011 D012 D013 D014 D015 D016
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
Manufacture Medical Device for Another Party (Contract Manufacturer)