Dreve Otoplastik GmbH
DE-MF-000005459 · Germany · Unna
Dreve Otoplastik GmbH is registered in the European database on medical devices as a manufacturer, with 456 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 446 |
|---|---|
| Class IIb | 10 |
Catalogue references include 0808, 0941ARO, 28120M, 28215, 28351M, 4250.
European nomenclature codes declared: Y214580.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Dreve Otoplastik GmbH (DE) · FDA 3003610251 |
| Devices in EUDAMED | 456 |
| Country of registration | Germany |
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: United States only. Dreve Otoplastik GmbH is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
44911220476 | supplemented | 2028-12-04 |