Galena Pharma Oy
FI-MF-000000588 · Finland · Kuopio
Galena Pharma Oy is registered in the European database on medical devices as a manufacturer, with 85 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 59 |
|---|---|
| Class IIb | 26 |
Most frequent device types declared: 350143, 360072.
Devices declared under this manufacturer
- Apteekki Antiseptinen Haavanpuhdiste 100 ml
- Apteekki Antiseptinen Haavanpuhdiste 100 ml suihke
- Apteq Fluzinc Hunaja 24 tabl.
- Femisan Cream emätinvoide 10g
- Galax peräruiske 2x5ml
- Mobilat Ice Strong 150 ml
- Mobilat Ice Strong kylmägeeli 75 ml
- Multi-Gyn FeuchtCreme + applikator 50g
- Refenum Ice gel cu efect local de răcire 150 ml
- Terveyskaista HOIVA Makrogoli 4000 Suolaton 10x12 g
- Wonderm Antisepti 100 ml
- Xyliderm 500ml
Showing 12 of 85 declared devices.
Catalogue references include 2021, 2175206, 350138, 350179, 745010, 745011.
European nomenclature codes declared: M9001, U0803, V9017, G0401, M040412, G020301.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 85 |
| 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 | 76 |
|---|---|
| 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. Galena Pharma Oy was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
CR-03-1162-806-22 | supplemented | 2027-06-30 |