SOPHYSA
FR-MF-000002870 · France · ORSAY
SOPHYSA is registered in the European database on medical devices as a manufacturer, with 132 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 94 |
|---|---|
| Class IIa | 37 |
| Class IIb | 1 |
Most frequent device types declared: PAK2, SPVA-2010, DE-210, SM8-2021, B905S-20.
Among these devices, 104 are declared sterile, 84 implantable, 1 active, 5 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 | Registered with FDA |
|---|---|
| Matched entry | SOPHYSA (FR) · FDA 3001587388 |
| Devices in EUDAMED | 132 |
| Country of registration | France |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
40171 | supplemented | 2030-03-05 |