CGI Suomi Oy
FI-MF-000012661 · Finland · Helsinki
CGI Suomi 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 IIa | 2 |
|---|---|
| Class IIb | 4 |
Most frequent device types declared: Kemokur 1.5, Merlot Medi Physio 3.0.4.
Among these devices, 6 are declared active.
Devices declared under this manufacturer
- Kemokur
- Merlot Medi Physio
- OMNI360 Kertomus
Catalogue references include Kemokur 1.5, Kemokur v3.0, Merlot Medi Physio 3.0.4, Merlot Medi Physio v3.1, OMNI360 Kertomus version 1.0, Pegasos v9.2.
European nomenclature codes declared: Z12040292, 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 | 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. CGI Suomi Oy was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
CR-03-1156-859-24 | supplemented | 2029-12-09 |