FROST Diagnostika GmbH
DE-MF-000034832 · Germany · Otterstadt
FROST Diagnostika GmbH is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: FD Anti-WGA IgG Elisa, FD Darm check professionell, FD FOB professionell Schnelltest, FD HIS-SUB Elisa, FD Hb/Hp complex professionell Schnelltest.
Devices declared under this manufacturer
- FD Anti-WGA IgG Elisa
- FD Darm check professionell
- FD FOB professionell
- FD HIS-SUB Elisa
- FD Hb/Hp complex professionell
- FD THAK/THDC Elisa
Catalogue references include FD E-3000, FD-N-DCH-20, FD-N-FOB, FD-N-HBHP-20, FD-THAK-192, FD-WGA-G-96.
European nomenclature codes declared: W0102019099, W01020209, W01020299.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 6 |
| 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 | 6 |
|---|---|
| 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. FROST Diagnostika GmbH was not found in either the U.S. or the Canadian register.