eemagine Medical Imaging Solutions GmbH
DE-MF-000005560 · Germany · Berlin
eemagine Medical Imaging Solutions GmbH is registered in the European database on medical devices as a manufacturer, with 253 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 253 |
|---|
Most frequent device types declared: CA-xxx/CY-xxx/CS-xxx/NA-xxx/NG-xxx/XC-xxx/XE-xxx/XS-xxx, EE-xxx, LE-200, LE-800, 666601.
Among these devices, 12 are declared active, 12 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 | EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH (DE) · FDA 9612389 |
| Devices in EUDAMED | 253 |
| Country of registration | Germany |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
44911222111 | issued | 2030-06-12 |