Fritz Stephan GmbH
DE-MF-000007591 · Germany · Gackenbach
Fritz Stephan GmbH is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 6 |
|---|---|
| Class IIa | 1 |
Most frequent device types declared: Oxylog 600, Oxylog 600 IC.
Among these devices, 1 are declared sterile, 6 active, 6 with a measuring function.
Catalogue references include 107161400, 107161401, 107161402, 107161420, 107161421, 107161422.
European nomenclature codes declared: Z1203010504, Z12030104, R0301010201.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 7 |
| 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 | 7 |
|---|---|
| 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. Fritz Stephan GmbH was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
0930GB448260213 | supplemented | 2027-06-10 |