Uniogen Oy
FI-MF-000032341 · Finland · Turku
Uniogen Oy 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
Most frequent device types declared: CDX-10, CDX-100, CDX-130, CDX-140, CDX-150.
Devices declared under this manufacturer
- GenomEra C. difficile Assay Kit
- GenomEra CDX Software
- GenomEra CDX System
- GenomEra GBS Assay Kit
- GenomEra HSV 1/2, VZV + EV Assay Kit
- GenomEra MRSA/SA AC Assay Kit
- GenomEra MRSA/SA Multi Swab Assay Kit
- GenomEra Norovirus Assay kit
- GenomEra S. pneumoniae Assay Kit
- GenomEra SARS-CoV-2 2.0 Assay Kit
- GenomEra SARS-CoV-2 Assay Kit
- GenomEra SARS-CoV-2, Flu A/B + RSV 2.0 Assay Kit
Showing 12 of 26 declared devices.
Catalogue references include CDX-10-020, CDX-130-01-40, CDX-140-01-20, CDX-150-01-100, CDX-170-01-20, CDX-40-01-40.
European nomenclature codes declared: W0105070302, W0105040519, W0105011804, W0105011203, W02050116, W0105011105.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 26 |
| Country of registration | Finland |
⚠️ 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. Uniogen Oy was not found in either the U.S. or the Canadian register.