Sedatelec
FR-MF-000020946 · France · Irigny
Sedatelec is registered in the European database on medical devices as a manufacturer, with 41 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 38 |
|---|---|
| Class IIb | 3 |
Among these devices, 25 are declared sterile, 3 implantable, 15 active.
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 | SEDATELEC (FR) · FDA 8020802 |
| Devices in EUDAMED | 41 |
| Country of registration | France |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G15 015735 0033 | supplemented | 2030-06-03 |