Oehm und Rehbein GmbH
DE-MF-000004977 · Germany · Rostock
Oehm und Rehbein GmbH 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 | 4 |
|---|---|
| Class IIb | 2 |
Devices declared under this manufacturer
- ORCA®
- dicomPACS®
- dicomPACS® MobileView
- dicomPACS®DX-R
Catalogue references include C1000, L1000, OC1000, SW1000.
European nomenclature codes declared: Z11031182, Z110603.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | OEHM UND REHBEIN GMBH (DE) · FDA 3006542593 |
| Devices in EUDAMED | 6 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 6 |
|---|---|
| Found in the U.S. device database | 5 |
| Share | 83.3 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | OEHM UND REHBEIN GMBH |
What it holds in Canada
| Licences on record | 2 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| First licensed | 2011-09-02 |
Licence types: System (2).
Licensed under: DICOMPACS DX-R, DICOMPACS.
North American profile: Both markets. Oehm und Rehbein GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
3048GB448231108 | issued | 2028-02-02 |