FDA device listing
Arena Pro series, iHear Pro, Nano Q Li, SmartEar Pro Li, Comma, UniSound RIC60, SmartEar Pro, Pockettio DHP,,Earlink OA…
FDA device listing 1677546027 · Xiamen Realink Hearing technology Co., Ltd
Key facts
| Proprietary names | Arena Pro series, iHear Pro, Nano Q Li, SmartEar Pro Li, Comma, UniSound RIC60, SmartEar Pro, Pockettio DHP,,Earlink OA Li, iEarton OA Li, iEarton 13Pro, iEarton 675Pro, iEarton MCIC, iEarton RIC312, RIC10, iEarton RIC-Pro,,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… |
|---|---|
| Owner/operator | Xiamen Realink Hearing technology Co., Ltd |
| Owner/operator number | 10089694 |
| Product codes | QUF |
| Device names | QUF - Hearing Aid, Air-Conduction, Over The Counter |
| Device class | Class I |
| Classification regulations (21 CFR) | 874.3300 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | XIAMEN REALINK HEARING TECHNOLOGY CO., LTD |
| Establishment registrations | 3020998569 |
| FEI numbers | 3020998569 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database