ONE ORTHO
FR-MF-000018482 · France · SAINT GENIS LAVAL
ONE ORTHO is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 5 |
|---|
Among these devices, 3 are declared active.
Devices declared under this manufacturer
- 2D HIP PLANNING SOFTWARE
- 3D HIP PLANNING SOFTWARE
- 3D KNEE PLANNING SOFTWARE
- OneScale
Catalogue references include DTR08 - 2D HIP PLANNING SOFTWARE, DTR09 - 3D HIP PLANNING SOFTWARE, DTR11 - 3D KNEE PLANNING SOFTWARE, DTR18, DTR18 - Dispositif de calibration 2D sur socle.
European nomenclature codes declared: Z12139082, Z11030580.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 5 |
| Country of registration | France |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 5 |
|---|---|
| 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. ONE ORTHO was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
40542 | supplemented | 2030-08-26 |