EUROLyser Diagnostica GmbH
AT-MF-000013746 · Austria · Salzburg
EUROLyser Diagnostica GmbH is registered in the European database on medical devices as a manufacturer, with 26 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Devices declared under this manufacturer
- CRP test kit (32 tests)
- CRP with integrated capillary test kit (32 tests)
- CUBE-S Analyser (700/546)
- Cystatin C (GFR) control kit
- Cystatin C (GFR) test kit (32 tests)
- D-Dimer control kit
- D-Dimer test kit (16 tests)
- D-Dimer test kit (6 tests)
- Ferritin test kit (16 tests)
- HbA1c control kit
- HbA1c test kit (24 tests)
- Lipoprotein (a) control kit
Showing 12 of 26 declared devices.
Catalogue references include ST0110, ST0150, ST0151, ST0171, ST0180, ST0240.
European nomenclature codes declared: W0102160801, W0102160601, W0103020803, W01021699, W010302080501, W0102160199.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 26 |
| Country of registration | Austria |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 2 |
|---|---|
| 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. EUROLyser Diagnostica GmbH was not found in either the U.S. or the Canadian register.