Scaffdex Oy
FI-MF-000012283 · Finland · Tampere
Scaffdex Oy is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 7 |
|---|---|
| Class I | 7 |
Most frequent device types declared: RG0002, RG0004, RG0005, RG0007, S02.
Among these devices, 7 are declared sterile, 7 implantable, 7 reusable.
Devices declared under this manufacturer
- RegJoint
- RegJoint sizer
Showing 12 of 14 declared devices.
Catalogue references include RG0002, RG0004, RG0005, S02, S03, S04.
European nomenclature codes declared: L091199, P900402.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 14 |
| 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 | 14 |
|---|---|
| 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. Scaffdex Oy was not found in either the U.S. or the Canadian register.