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: 666601, CA-xxx/CY-xxx/CS-xxx/NA-xxx/NG-xxx/XC-xxx/XE-xxx/XS-xxx, EE-xxx, LE-200, LE-800.
Among these devices, 12 are declared active, 12 with a measuring function.
Devices declared under this manufacturer
- eego
- eego amplifier
- neo monitor
- visor2
- waveguard
- waveguard connect
- waveguard net
- waveguard original
Showing 12 of 253 declared devices.
Catalogue references include CA-143, CA-175, CA-431, XC-001, XC-126, XE-295.
European nomenclature codes declared: N01010203, Z12100380, N01010299, Z12100302, Z12100385, Z12109099.
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 |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH |
What it holds in Canada
| Licences on record | 4 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 3 |
| Class 3 devices | 1 |
| First licensed | 2012-05-03 |
Licence types: System (4).
Licensed under: VISOR2, WAVEGUARD EEG CAP AND ACCESSORIES, EEGO SYSTEM, NEO MONITOR SYSTEM.
North American profile: Both markets. eemagine Medical Imaging Solutions GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
44911222111 | issued | 2030-06-12 |