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: UNIC® Reverse Shoulder, JUST UNIC® , Femoral stem instruments, INTERFERENCE SCREWS.
Among these devices, 81 are declared sterile, 81 implantable, 37 reusable, 12 with a measuring function.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 130 |
| Country of registration | France |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.
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074-00-00-MDR | withdrawn | 2030-04-21 |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 |