Biochem Bernburg GmbH
DE-MF-000036372 · Germany · Mansfeld
Biochem Bernburg GmbH is registered in the European database on medical devices as a manufacturer, with 91 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 91 |
|---|
Most frequent device types declared: Biogran K244 100, Dialysis concentrate powder, Magnesium-Chlorid 17,8 % 100ml, Salzkonzentrat 3BN-1.000 L, Salzkonzentrat BRX-900 L.
Among these devices, 1 are declared sterile.
Devices declared under this manufacturer
- Biogran
Showing 12 of 91 declared devices.
Catalogue references include 2827 31 00-5, 701039304, 71000820, 71000931, 71001892, 711138210.
European nomenclature codes declared: F040201, F040101.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 91 |
| 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 | 90 |
|---|---|
| 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. Biochem Bernburg GmbH was not found in either the U.S. or the Canadian register.