THALES AVS FRANCE SAS
FR-MF-000012704 · France · Mérignac
THALES AVS FRANCE SAS is registered in the European database on medical devices as a manufacturer, with 49 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 48 |
|---|---|
| Class IIb | 1 |
Most frequent device types declared: PIXIUM PORTABLE 2430 EZ-C.
Among these devices, 49 are declared active.
Devices declared under this manufacturer
- ArtPix Mobile EZ2GO
- CONVERTER
- PIXIUM DYNAMIC
- PIXIUM STATIC
- PROCESSING UNIT
Showing 12 of 49 declared devices.
Catalogue references include PIXIUM PORTABLE 2430 EZ-C A, PIXIUM PORTABLE 3543 EZ-C, PIXIUM PORTABLE 3543 EZ-C X D, PIXIUM RAD 4343 C-E, PIXIUM RF 4343 F4, PIXIUM SURGICAL 2121S-AU2 F.
European nomenclature codes declared: Z11031101, Z11031180.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | THALES AVS FRANCE SAS (FR) · FDA 3004077520 |
| Devices in EUDAMED | 49 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 49 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 2.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | THALES AVS FRANCE SAS |
What it holds in Canada
| Licences on record | 2 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| First licensed | 2021-03-26 |
Licence types: System (1), Device Family (1).
Licensed under: ARTPIX MOBILE EZ2GO, PIXIUM PORTABLE EZ.
North American profile: Both markets. THALES AVS FRANCE SAS is registered in both the United States and Canada.