FDA Registration
Active
🇨🇳 China
Anese 313, Anese 315, iEarton RIC80, iEarton MCIC10
Reg #: 3020998569
·
FEI: 3020998569
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- XIAMEN REALINK HEARING TECHNOLOGY CO., LTD
- Registration Number
- 3020998569
- FEI Number
- 3020998569
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Rm. B805, Jianye Bld, No.96, XIANGXING rd, Xiang'an TORCH HI-TECH ZONE,
- City
- XIAMEN Fujian
- Country
- CN
Owner / Operator
- Firm Name
- Xiamen Realink Hearing technology Co., Ltd
- Operator Number
- 10089694
- Address
- Rm. B805, Jianye Bld, No.96, XIANGXING rd, Xiang'an TORCH HI-TECH ZONE,
- City
- XIAMEN
- State
- Fujian
- Postal Code
- 361021
- Country
- CN
- Correspondent
- HUIMIN WANG
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hearing Aid, Air-Conduction, Prescription | ESD | Class 1 | Ear, Nose, Throat | No | 2023-12-29 |
Proprietary Names
Anese 313, Anese 315, iEarton RIC80, iEarton MCIC10
iEarton MCIC, iEarton RIC312, RIC10, iEarton RIC-Pro, Arena Pro series, iHear Pro, Nano Q Li; Starry CIC Li
Shine CIC BT-Li, UniSound RIC60, MCIC80, Pockettio DHP, Pockettio HP, Dynamic Li
Dynamic BT Li, Startone 10, Clear108, GoodSound Pro, USB Charging ITC
Hearing aid, air conduction:Realink R BT-Li, Vivo2, Vivo111, Vivo9SP, Earlink 13P, iEarton OA Li, iEarton 13Pro, iEarto
Establishment Types
Manufacture Medical Device