EUDAMED device
Pristina Duo
EUDAMED device 00198953051016 · GE Medical Systems SCS
Key facts
| Primary DI | 00198953051016 |
|---|---|
| Trade name | Pristina Duo |
| Device name | Senographe Pristina |
| Reference or catalog number | 5985307 |
| Model | MBE2 |
| Manufacturer | GE Medical Systems SCS |
| Manufacturer SRN | FR-MF-000000687 |
| Risk class | Class IIb |
| EMDN code | Z11030202 |
| EMDN description | DIGITAL MAMMOGRAPHY SYSTEMS |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Jul 10, 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: