Owandy Radiology S.a.s
FR-MF-000010352 · France · Croissy Beaubourg
Owandy Radiology S.a.s is registered in the European database on medical devices as a manufacturer, with 31 devices declared. It has a similarly named entry in the FDA register that we have not verified.
What this manufacturer declares
| Class IIb | 31 |
|---|
Most frequent device types declared: Dental intraoral x-ray equipment AC.
Among these devices, 31 are declared active.
Devices declared under this manufacturer
- Owandy-RX AC
Showing 12 of 31 declared devices.
Catalogue references include 5.90.15604, 5.90.22601, 5.90.23604, 5.91.15605, 5.91.22601, 5.91.22602.
European nomenclature codes declared: Z1103040101,Z1103040102.
United States market access
| FDA establishment register | Similar name found — unverified |
|---|---|
| Matched entry | OWANDY RADIOLOGY (FR) · FDA 9615832 |
| Devices in EUDAMED | 31 |
| Country of registration | France |
⚠️ A similar name exists; we do not assert it is the same company — why.
Device-level evidence
| Devices with a numeric GTIN | 31 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Similar name found — unverified |
|---|---|
| Matched entry | OWANDY RADIOLOGY |
⚠️ A similar name exists; unverified — why.
What it holds in Canada
| Licences on record | 7 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 6 |
| Class 3 devices | 1 |
| First licensed | 2014-07-28 |
Licence types: Device Family (5), System (1), Device Group Family (1).
Licensed under: OPTEO, ONE, I-MAX, I-MAX 3D, OWANDY-RX PRO, OWANDY-RX DC.