EUDAMED device
Omni
EUDAMED device 00198953006849 · GE Medical Systems Israel", Functional Imaging
Key facts
| Primary DI | 00198953006849 |
|---|---|
| Trade name | Omni |
| Device name | Omni |
| Reference or catalog number | PCM-PET0014 |
| Model | PCM-PET0014 |
| Manufacturer | GE Medical Systems Israel", Functional Imaging |
| Manufacturer SRN | IL-MF-000003062 |
| Risk class | Class IIb |
| EMDN code | Z11020301 |
| EMDN description | CT/PET SYSTEMS |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Nov 26, 2025 |
At a glance
- No Matching FDA GUDID record
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About EUDAMED devices
EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.
Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date: