One Ortho
Active in EUDAMEDFrancefrom SRN EUDAMED SRN FR-MF-000018482
- Devices
- 7
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
Catalogue
- CE MDR EUDAMED
- CE MDR EUDAMED
3D Hip Planning Software Ref DTR09 - 3D HIP PLANNING SOFTWARE
CE MDR EUDAMEDOneScale Ref DTR18
CE MDR EUDAMED3D Knee Planning Software Ref DTR11 - 3D KNEE PLANNING SOFTWARE
CE MDR EUDAMED2D Hip Planning Software Ref K261352
510(k) 510(k)2D Hip Planning Software Ref DTR08 - 2D HIP PLANNING SOFTWARE
CE MDR EUDAMED
Company details
- EUDAMED SRN
- FR-MF-000018482
- EU VAT number
- FR46 795 284 355
- EUDAMED status
- Active
- EUDAMED registered name
- ONE ORTHO
- Registered address
- 206, Route de Vourles, 69230, SAINT GENIS LAVAL, France
- [email protected]
- PRRC contact
- Théo VIDAL
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 26 Aug 2030
GMED SAS 0459 1 certificate
- 40542 Supplemented
Quality management system EU MDR
- Issued
- 25 Aug 2026
- Expires
- 26 Aug 2030
- Reason
- Other
Frequently asked questions
How many devices does ONE ORTHO have in the registry?
The registry currently lists 7 devices for ONE ORTHO. Devices recorded under merged duplicate company entries are counted once.
Which registries list ONE ORTHO's devices?
Among its 7 most recently registered devices, ONE ORTHO has devices listed in EUDAMED (6 devices) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do ONE ORTHO's devices fall under?
Among its 7 most recently registered devices, the classes recorded for ONE ORTHO's devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for ONE ORTHO?
EUDAMED lists 1 certificate for ONE ORTHO (quality management system) under MDR. The most recent was issued on 2026-08-25.
What are the newest devices from ONE ORTHO in the registry?
The most recently registered devices listed for ONE ORTHO include OneScale, 3D SHOULDER PLANNING SOFTWARE, 3D HIP PLANNING SOFTWARE and 3D KNEE PLANNING SOFTWARE.