GN Hearing A/S
DK-MF-000009536 · Denmark · Ballerup
GN Hearing A/S is registered in the European database on medical devices as a manufacturer, with 684 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 684 |
|---|
Most frequent device types declared: BTE, Charger, FSW, ITC, ITE.
Among these devices, 652 are declared active.
Catalogue references include 24122875, 24124873, 24125770, 24126573, 24127172, 24127474.
European nomenclature codes declared: Y2145060102, Y2145060202, Y214580, Y2145060203, Y2145060201, Y2145060101.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | GN Hearing A/S (DK) · FDA 3005650109 |
| Devices in EUDAMED | 684 |
| Country of registration | Denmark |
Device-level evidence
| Devices with a numeric GTIN | 684 |
|---|---|
| Found in the U.S. device database | 168 |
| Share | 24.6 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | GN HEARING A/S |
What it holds in Canada
| Licences on record | 15 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 15 |
| First licensed | 2010-04-26 |
Licence types: Single Device (8), Device Family (7).
Licensed under: REMOTE CONTROL, PHONE CLIP +, PHONE LINK 2, RESOUND MICRO MIC, RESOUND MULTI MIC, BELTONE MYPAL PRO.
North American profile: Both markets. GN Hearing A/S is registered in both the United States and Canada.