EDAP TMS FRANCE
FR-MF-000002207 · France · Vaulx-En-Velin
EDAP TMS FRANCE is registered in the European database on medical devices as a manufacturer, with 15 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 9 |
|---|---|
| Class IIa | 6 |
Most frequent device types declared: Sonolith i-move Touch, EB, Sonolith i-move Visio-track, Sonolith i-move Standard.
Among these devices, 11 are declared 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 | EDAP TMS France SA (FR) · FDA 9612448 |
| Devices in EUDAMED | 15 |
| Country of registration | France |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
39982 | supplemented | 2029-09-01 |