FDA Registration
Active
🇨🇳 China
Bro Series, Eggo Series, Gio Series, K Series, Smart Series, Smart U Series, Vigor Series, Vigor U Series
Reg #: 3010408889
·
FEI: 3010408889
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- XIAMEN RETONE HEARING TECHNOLOGY CO., LTD.
- Registration Number
- 3010408889
- FEI Number
- 3010408889
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Room 209, 2nd floor, No. 999 Tianma Road, Jimei District
- City
- Xiamen Fujian
- Country
- CN
Owner / Operator
- Firm Name
- Xiamen Retone Hearing Technology Co., Ltd.
- Operator Number
- 10044151
- Address
- Room 209, 2nd floor, No. 999 Tianma Road, Jimei District
- City
- Xiamen
- State
- Fujian
- Postal Code
- 361000
- Country
- CN
US Agent
- Business Name
- IRC USA
- Contact Name
- Charles Mack
- Address
- 2950 E Lindrick Dr.
- City
- Chandler
- State
- AZ
- ZIP
- 85249
- Country
- US
- [email protected]
- Phone
- 931 6254938
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hearing Aid, Air-Conduction, Over The Counter | QUF | Class 1 | Ear, Nose, Throat | No | 2022-10-21 |
Proprietary Names
Bro Series, Eggo Series, Gio Series, K Series, Smart Series, Smart U Series, Vigor Series, Vigor U Series
Echo Series, Atom, Atom Pro, Atom 2, Atom pro2, Atom One, Neo, Neo XS, HEARIZON
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)