EVOLUTIS
FR-MF-000000492 · France · BRIENNON
EVOLUTIS is registered in the European database on medical devices as a manufacturer, with 130 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class I | 81 |
|---|---|
| Class IIa | 49 |
Most frequent device types declared: Femoral stem instruments, INTERFERENCE SCREWS, JUST UNIC®, UNIC® Reverse Shoulder.
Among these devices, 81 are declared sterile, 81 implantable, 37 reusable, 12 with a measuring function.
Devices declared under this manufacturer
- FIXIO PENTA interference screw
- FIXION PENTA Interference screw
- FIXION PENTA interference screw
- Instruments Prothèse de Genou
- Instruments pour Cotyles
- Instruments pour Prothèse d’Epaule
- Instruments pour tiges fémorales
- JUST UNIC®
- UNIC®
- UNIC® Reverse Shoulder
Showing 12 of 130 declared devices.
Catalogue references include E27 002, E27 200RD2, E27 220, E27 425RS, E27 540, E28 T104.
European nomenclature codes declared: L091199, P09018001, P0901040201, P0901040204, P09120606, L091104.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 130 |
| 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 | 130 |
|---|---|
| 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. EVOLUTIS was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
074-00-00-MDR | withdrawn | 2030-04-21 |
055-00-00-MDR | issued | 2029-09-11 |
017-00-00-MDR | issued | 2028-04-05 |
016-00-04-MDR | supplemented | 2028-04-05 |