EOS imaging
FR-MF-000000502 · France · Paris
EOS imaging is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 7 |
|---|
Most frequent device types declared: EOSedge Chair.
Among these devices, 1 are declared reusable, 5 active, 5 with a measuring function.
Devices declared under this manufacturer
- AutoDensity
- EOSedge Chair
- Radioluscent chair
- VEA Align
- sterEOS
Catalogue references include 9000113040, 9000116089, AutoDensity, VEA Align, sterEOS.
European nomenclature codes declared: Z11030592, V080202, Z11069005, Z11900192.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | EOS imaging (FR) · FDA 3006165260 |
| Devices in EUDAMED | 7 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 7 |
|---|---|
| Found in the U.S. device database | 6 |
| Share | 85.7 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | EOS IMAGING |
What it holds in Canada
| Licences on record | 3 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 3 |
| First licensed | 2007-06-11 |
Licence types: Device Group (1), System (1), Single Device (1).
Licensed under: EOS X-RAY IMAGING SYSTEM, STEREOS WORKSTATION SYSTEM, EOSEDGE.
North American profile: Both markets. EOS imaging is registered in both the United States and Canada.