O&P Solutions AB
SE-MF-000057141 · Sweden · Järfälla
O&P Solutions AB is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 9 |
|---|
Most frequent device types declared: Joint, SolutionX Core AFO.
Devices declared under this manufacturer
- SolutionX Apex AFO
- SolutionX Core AFO
- SolutionX Joint
Catalogue references include SX-APX-L-L, SX-APX-L-R, SX-APX-M-L, SX-CR-L-L, SX-CR-L-R, SX-CR-M-L.
European nomenclature codes declared: Y06120601.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 9 |
| Country of registration | Sweden |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 9 |
|---|---|
| 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. O&P Solutions AB was not found in either the U.S. or the Canadian register.