DigiFinland Oy
FI-MF-000002451 · Finland · Helsinki
DigiFinland Oy 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
| Class IIb | 2 |
|---|---|
| Class IIa | 4 |
Most frequent device types declared: Navigaattoripalvelu, Omaolo.
Among these devices, 6 are declared active.
Devices declared under this manufacturer
- Navigaattoripalvelu
- Omaolo
Catalogue references include Navi01, Oma01, Oma02.
European nomenclature codes declared: V92.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 6 |
| 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 | 5 |
|---|---|
| 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. DigiFinland Oy was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
FI22/871876 | supplemented | 2025-05-15 |
FI22/871876 | supplemented | 2028-05-15 |