Ab Fatex Oy
FI-MF-000041039 · Finland · Kronoby
Ab Fatex Oy is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 10 |
|---|
Most frequent device types declared: Bibs, Protective Sheet.
Devices declared under this manufacturer
- 10-3031347 Protection Sheet 140
- 10-3061347 Protection sheet 210
- 101001 Cellbasic Underlägg 38x39 cm
- 20-1492360 Bibs 2 ply 38x68
- 20-2492317 Bibs 3 ply 38x68cm
- 401001 Skyddslakan Special Light 78x175
- 401002 Skyddslakan Special Light 78x210
- 401004 Skyddslakan Special Light 78x140
- 621002 Haklapp Knyt 37x66 cm
- Cellbasic Special Britsskydd 78x210 cm
European nomenclature codes declared: T030502, T0299, T04010299.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 10 |
| 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 | 10 |
|---|---|
| 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. Ab Fatex Oy was not found in either the U.S. or the Canadian register.