Group Unikulma Oy
FI-MF-000016906 · Finland · Vantaa
Group Unikulma Oy is registered in the European database on medical devices as a manufacturer, with 75 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 75 |
|---|
Devices declared under this manufacturer
- SteadyBody aluslakana 180x270 sininen
- SteadyBody aluslakana 275x275 harmaa
- SteadyBody aluslakana 275x275 minttu
- SteadyBody kirjekuorilakana 105x210x6 valkoinen
- SteadyBody kirjekuorilakana 120x200x6, valkoinen
- SteadyBody kirjekuorilakana 210x210x6
- SteadyBody pillow case 40x80 white
- SteadyBody pussilakana 150x210 sininen
- SteadyBody tyynyliina 55x65 sininen
- SteadyBody tyynyliina 60x80 lila
- Steadybody kirjekuorilakana 105x210x6cm, hopea
- Steadybody kirjekuorilakana 80x200x6cm, harmaa
Showing 12 of 75 declared devices.
Catalogue references include LAKSTE080KLHA, LAKSTE1051KLHO, LAKSTE1051KLV, LAKSTE150PLTU, LAKSTE2101KLV, LAKSTE275MI.
European nomenclature codes declared: V9099.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 75 |
| 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 | 75 |
|---|---|
| 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. Group Unikulma Oy was not found in either the U.S. or the Canadian register.