EUDAMED device
Pristina Serena
EUDAMED device 00195278347596 · GE Medical Systems SCS
Key facts
| Primary DI | 00195278347596 |
|---|---|
| Trade name | Pristina Serena |
| Device name | Pristina Serena |
| Reference or catalog number | 7201138-2 |
| Model | Pristina Serena |
| Manufacturer | GE Medical Systems SCS |
| Manufacturer SRN | FR-MF-000000687 |
| Risk class | Class IIb |
| EMDN code | Z1103028001 |
| EMDN description | STEREOTACTIC MODULES FOR MAMMOGRAPHY |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Jan 9, 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: