FDA device listing
Enhance Select 100,Enhance Select 200,Enhance Select 300,Enhance Select 50,Enhance Select 500,Enhance Select 50R,Enhance…
FDA device listing 1397123190 · GN Hearing A/S
Key facts
| Proprietary names | Enhance Select 100,Enhance Select 200,Enhance Select 300,Enhance Select 50,Enhance Select 500,Enhance Select 50R,Enhance Select 700,Multi Mic,Phone Clip Plus,SureFit,sport lock,TV Streamer 2 |
|---|---|
| Owner/operator | GN Hearing A/S |
| Owner/operator number | 2182204 |
| Product codes | QUG |
| Device names | QUG - Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter |
| Device class | Class II |
| Classification regulations (21 CFR) | 874.3305 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | GN Hearing A/S, GN Hearing Care Corporation, GN RESOUND CHINA, LTD., GN ReSound (Malaysia) Sdn Bhd., GN ReSound (Malaysia) Sdn. Bhd |
| Establishment registrations | 2182204, 3003303986, 3005650109, 3011927597, 3026048380 |
| FEI numbers | 2182204, 3003303986, 3005650109, 3011927597, 3026048380 |
| Establishment operations | Contract Manufacturer, Foreign Exporter, Specification Developer |
| 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