Oiva Health Oy
FI-MF-000045801 · Finland · Tampere
Oiva Health Oy is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 8 |
|---|
Most frequent device types declared: 181416, 283799, 425515, 631177, 786568.
Among these devices, 8 are declared active.
Devices declared under this manufacturer
- Screening Tool (Terveyden riskitestit)
Catalogue references include MQ-ANX-794349, MQ-CVD-922192, MQ-DEPR-181416, MQ-DEPR-425515, MQ-DEPR-631177, MQ-DEPR-786568.
European nomenclature codes declared: V92.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 8 |
| 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 | 1 |
|---|---|
| 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. Oiva Health Oy was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
FI26/0000002 | issued | 2031-01-16 |