Acousticon Hörsysteme GmbH
DE-MF-000013831 · Germany · Reinheim
Acousticon Hörsysteme GmbH is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 5 |
|---|
Among these devices, 5 are declared active, 5 with a measuring function.
Devices declared under this manufacturer
- ACAM 5 Hardware
- ACAM 5 Modul Audiometer
- ACAM 5 Modul Hörfelddiagnose
- ACAM 5 Modul Insitu
- ACAM 5 Modul Messbox
Catalogue references include A0102400, A0102401, A1024536, A1025050, A1025051.
European nomenclature codes declared: V92, V0399.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 5 |
| Country of registration | Germany |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 5 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. Acousticon Hörsysteme GmbH was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
1379GB449250929 | issued | 2029-09-23 |