FDA Registration
Active
🇨🇳 China
XIAMEN REALINK HEARING TECHNOLOGY CO., LTD
Reg #: 3020998569
·
FEI: 3020998569
·
Expires 2026
Products
4
Proprietary Names
16
Establishment Types
1
Classifications
4
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Registration Details
- Registration Name
- XIAMEN REALINK HEARING TECHNOLOGY CO., LTD
- Registration Number
- 3020998569
- FEI Number
- 3020998569
- Status
- Active
- Expiry Year
- 2026
- 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 |
| Face Plate Hearing Aid | LRB | Class 1 | Ear, Nose, Throat | No | 2023-12-29 |
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | QUG | Class 2 | Ear, Nose, Throat | No | 2023-12-29 |
| Hearing Aid, Air-Conduction, Over The Counter | QUF | Class 1 | Ear, Nose, Throat | No | 2023-12-29 |
Proprietary Names
Pockettio HP, Dynamic Li, Dynamic BT Li, Startone 10, Clear108, GoodSound Pro, USB Charging ITC, Anese 313,
Arena Pro series, iHear Pro, Nano Q Li, Pockettio Pro, Shine CIC BT-Li, UniSound RIC60, SmartEar Li, Pockettio DHP,
iEarton OA Li, iEarton 13Pro, iEarton 675Pro, iEarton MCIC, iEarton RIC312, RIC10, iEarton RIC-Pro,
Hearing aid, air conduction:Realink R BT-Li, Vivo2, Vivo111, Vivo9SP, Earlink 13P,
Anese 315, iEarton RIC80, iEarton MCIC10, SmartEar Pro
Realink FP-Pro, iEarton FP CIC 100, iEarton FP Pro CIC 600,
Earlink FP-Pro, Nano Q FP-Pro, Ecoute FP-Pro, UniSound FP-Pro, Vivo FP, Starry FP-Pro, Shine FP-Pro, Starry CIC
Face plate hearing aid :Faceplate hearing aid, ARENA FP-Pro, iHear FP-Pro,
Realink R BT-Li, Starry CIC BT, Shine CIC BT, UniSound Li, MCIC 10, Pockettio DHP Li, Pockettio HP Li, Dynamic Li,
HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY, OVER THE COUNTER:
Dynamic BT Li, Earlink BT Li, GoodSound Pro, SmartEar Pro, Pockettio Pro, SmartEar Li, SmartEar Pro Li
iEarton FP CIC, iEarton FP ITC, Earlink FP CIC, Earlink FP ITC, iEarton FP-Pro, iEarton FP-BT, iEarton FP-R,
Arena Pro series, iHear Pro, Nano Q Li, SmartEar Pro Li, Comma, UniSound RIC60, SmartEar Pro, Pockettio DHP,
hearing aid air conduction, Over-the-counter hearing aid:R BT-Li, Vivo2, Vivo111, Vivo9SP, Vivo Fun, Earlink 13P,
Pockettio HP, Dynamic Li, Dynamic BT Li, SmartEar Li, Clear108, Pockettio Pro Li, USB Charging ITC
Earlink OA Li, iEarton OA Li, iEarton 13Pro, iEarton 675Pro, iEarton MCIC, iEarton RIC312, RIC10, iEarton RIC-Pro,
Establishment Types
Manufacture Medical Device