IMAGE Information Systems Europe GmbH
DE-MF-000004979 · Germany · Rostock
IMAGE Information Systems Europe GmbH is registered in the European database on medical devices as a manufacturer, with 18 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 10 |
|---|---|
| Class IIb | 8 |
Among these devices, 18 are declared active, 6 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 | IMAGE INFORMATION SYSTEMS EUROPE GmbH (DE) · FDA 3006165530 |
| Devices in EUDAMED | 18 |
| Country of registration | Germany |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
3420GB448240326 | issued | 2028-02-14 |