EUDAMED device
Omni Legend
EUDAMED device 00195278454218 · GE Medical Systems, LLC
Key facts
| Primary DI | 00195278454218 |
|---|---|
| Trade name | Omni Legend |
| Device name | Omni Legend |
| Reference or catalog number | PCM-PET0012 |
| Model | Omni Legend |
| Manufacturer | GE Medical Systems, LLC |
| Manufacturer SRN | US-MF-000018315 |
| Risk class | Class IIb |
| EMDN code | Z11020301 |
| EMDN description | CT/PET SYSTEMS |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Nov 10, 2025 |
At a glance
- Yes 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: