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 IIb | 8 |
|---|---|
| Class IIa | 10 |
Among these devices, 18 are declared active, 6 with a measuring function.
Devices declared under this manufacturer
- iQ-4VIEW 2.2
- iQ-4VIEW 2.4
- iQ-LITE 3.0.0
- iQ-LITE 3.1
- iQ-ROBOT/PRO/ PREMIUM 4.0
- iQ-ROUTER 5.0
- iQ-ROUTER 5.1
- iQ-VIEW 4.0
- iQ-VIEW 4.1
- iQ-VIEW/PRO 3.0.0
- iQ-VIEW/PRO 3.1
- iQ-WEB 6.7.3
Showing 12 of 18 declared devices.
Catalogue references include IQ4VIEW24, IQLITE300, IQLITE31, IQROUTER51, IQVIEW40, IQVIEW41.
European nomenclature codes declared: Z110603.
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 |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. IMAGE Information Systems Europe GmbH is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
3420GB448240326 | issued | 2028-02-14 |