Frestems Oy
FI-MF-000001837 · Finland · Sastamala
Frestems Oy is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 13 |
|---|
Devices declared under this manufacturer
- ERGOMY Lite
- Ergomy Basic
- Ergomy Carbon
- Ergomy TOTAL
- Ergomy Total
- Pensi CARBON
- ProMIL 217
- ProMIL 245
- ProMIL Wheels
Showing 12 of 13 declared devices.
Catalogue references include 34000, 35178, 35468, 35781, 36931, 39878.
European nomenclature codes declared: V0805038001, V08050199.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 13 |
| 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 | 13 |
|---|---|
| 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. Frestems Oy was not found in either the U.S. or the Canadian register.