Image Wear Oy
FI-MF-000018231 · Finland · Tampere
Image Wear Oy is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 7 |
|---|
Most frequent device types declared: 4F013.
Devices declared under this manufacturer
- ERGO-Siirtosuoja
- Poikkilakana 80 x 150 cm
Catalogue references include 4F013A24560L, 4F013A24560M, 4F013A24560S, 4F013A24560XL, 4F013A24560XXL, 60393437560.
European nomenclature codes declared: T020402, Z12011299, T020199.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 7 |
| 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 | 7 |
|---|---|
| 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. Image Wear Oy was not found in either the U.S. or the Canadian register.