ArcDia International Oy Ltd
FI-MF-000007553 · Finland · Turku
ArcDia International Oy Ltd is registered in the European database on medical devices as a manufacturer, with 53 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Devices declared under this manufacturer
- mariPOC® Analyser
- mariPOC® Bottletop dispenser stand
- mariPOC® Gastro CDI combi test plate
- mariPOC® Gastro sample buffer
- mariPOC® Influenza A virus test reagent
- mariPOC® Norovirus GI test reagent
- mariPOC® Parainfluenza virus 1 test reagent
- mariPOC® Pharyn control samples
- mariPOC® Pneumococcus respiratory test reagent
- mariPOC® Quick Flu+ test plate
- mariPOC® RTI combi test plate
- mariPOC® SARS-2 control samples
Showing 12 of 53 declared devices.
Catalogue references include 1124MC, 1224M, 1R11, 2027M, A-1, A-29.
European nomenclature codes declared: W0201020299, W0105070599, W0599, W0105040604, W01050799, W0105011101.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 53 |
| 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 | 21 |
|---|---|
| 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. ArcDia International Oy Ltd was not found in either the U.S. or the Canadian register.