FDA device listing
Enhance Plus
FDA device listing 1062251527 · GN Hearing A/S
Key facts
| Proprietary names | Enhance Plus |
|---|---|
| Owner/operator | GN Hearing A/S |
| Owner/operator number | 2182204 |
| Product codes | QUH |
| Device names | QUH - Self-Fitting Air-Conduction Hearing Aid, Over The Counter |
| Device class | Class II |
| Classification regulations (21 CFR) | 874.3325 |
| 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 | Complaint File Establishment, 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