GLEAMER
FR-MF-000011358 · France · Paris
GLEAMER is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 6 |
|---|
Most frequent device types declared: BoneView / ChestView.
Among these devices, 6 are declared active, 3 with a measuring function.
Devices declared under this manufacturer
- BoneCT
- BoneView
- BreastView
- ChestView
- LumbarMR
- LungCT
Catalogue references include BoneCT, BoneView, BreastView, ChestView, LumbarMR, LungCT.
European nomenclature codes declared: Z11039082, Z11039092.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | GLEAMER (FR) · FDA 3021907554 |
| Devices in EUDAMED | 6 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 6 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | GLEAMER |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| First licensed | 2025-02-21 |
Licence types: Single Device (1).
Licensed under: BONEVIEW.
North American profile: Both markets. GLEAMER is registered in both the United States and Canada.