Orion Oyj
FI-MF-000001595 · Finland · Espoo
Orion Oyj is registered in the European database on medical devices as a manufacturer, with 23 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 23 |
|---|
Among these devices, 1 are declared active.
Devices declared under this manufacturer
- Movex Ice MSM Kylmägeeli
- Movex Ice Roll Kylmägeeli
- Nasolin Humidose
- Remo-Wax
- Remo-Wax Oil
- Remo-Wax Spray
- Remo-Wax korvasuihke 10 ml
- Remo-Wax korvatipat
- Remo-Wax korvatipat 10 ml
- Remo-wax Olie
- Remo-wax øredråber
- Remo-wax ørespray
Showing 12 of 23 declared devices.
Catalogue references include 112116, 141482, 142904, 142905, 142908, 163521.
European nomenclature codes declared: Q030499, M9001, Q030103, Z12069092.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 23 |
| 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 | 23 |
|---|---|
| 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. Orion Oyj was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
CR-03-1230-861-24 | supplemented | 2028-12-22 |