FDA Registration
Active
🇨🇳 China
XIAMEN RETONE HEARING TECHNOLOGY CO., LTD.
Reg #: 3010408889
·
FEI: 3010408889
·
Expires 2026
Products
5
Proprietary Names
9
Establishment Types
3
Classifications
5
Registration Details
- Registration Name
- XIAMEN RETONE HEARING TECHNOLOGY CO., LTD.
- Registration Number
- 3010408889
- FEI Number
- 3010408889
- Status
- Active
- Expiry Year
- 2026
- 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 With Wireless Technology, Over The Counter | QUG | Class 2 | Ear, Nose, Throat | No | 2022-10-21 |
| Hearing Aid, Air-Conduction, Over The Counter | QUF | Class 1 | Ear, Nose, Throat | No | 2022-10-21 |
| Hearing Aid, Air-Conduction, Prescription | ESD | Class 1 | Ear, Nose, Throat | No | 2013-05-07 |
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | Class 2 | Ear, Nose, Throat | No | 2022-10-21 |
| Face Plate Hearing Aid | LRB | Class 1 | Ear, Nose, Throat | No | 2013-05-07 |
Proprietary Names
Behind-The-Ear Hearing Aid
In-The-Ear Hearing Aid
K Series, Gio Series, Echo Series, Bright Series, Smart Series
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
K818SP-P, K218SP, K18S, Vigor 402BT-P, Vigor 402P
Bright Series, Clear Series
In-The-Ear Hearing Aid (Faceplate Kits Included)
Clear Series
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device