Dr. Berndsen GmbH
DE-MF-000005561 · Germany · Unna
Dr. Berndsen GmbH is registered in the European database on medical devices as a manufacturer, with 37 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 37 |
|---|
Most frequent device types declared: DI-FF-BW.
Devices declared under this manufacturer
- FaceFormer ONE blue
- FaceFormer ONE clear
- FaceFormer ZERO
- FaceFormer ZERO plus ONE
Showing 12 of 37 declared devices.
Catalogue references include DI-FF-BPT, DI-FF-KW, DI-FFD-GPT, DI-FFD-GS, DI-FFD-GW, DI-FFD-KPR.
European nomenclature codes declared: Q010499,Q03010299,V0899,Y99.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 37 |
| 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 | 37 |
|---|---|
| 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. Dr. Berndsen GmbH was not found in either the U.S. or the Canadian register.