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.
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 | GLEAMER (FR) · FDA 3021907554 |
| Devices in EUDAMED | 6 |
| Country of registration | France |