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: EB, Sonolith i-move Standard, Sonolith i-move Touch, Sonolith i-move Visio-track.
Among these devices, 11 are declared active.
Devices declared under this manufacturer
- Ablapak Set
- Endorectal probe
- Focal One
- Focal One endorectal probe
- Focal One®
- FocalPak® Set
- Focalpak Set
- Sonolith
Showing 12 of 15 declared devices.
Catalogue references include 239357, TMS 233101, TMS 234780, TMS 239270, TMS 239271, TMS 253728.
European nomenclature codes declared: U99, Z12160101, U1299, Z12011202, Z12160185, Z12011299.
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 |
Device-level evidence
| Devices with a numeric GTIN | 15 |
|---|---|
| Found in the U.S. device database | 10 |
| Share | 66.7 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | EDAP TMS FRANCE |
What it holds in Canada
| Licences on record | 2 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 2 |
| First licensed | 2008-10-27 |
Licence types: Device Group Family (1), Device Group (1).
Licensed under: SONOLITH I-SYS, FOCAL ONE.
North American profile: Both markets. EDAP TMS FRANCE is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
39982 | supplemented | 2029-09-01 |