EUDAMED device
Versana Premier, Versana Premier Lotus
EUDAMED device 00195278690395 · GE Medical Systems CO. Ltd
Key facts
| Primary DI | 00195278690395 |
|---|---|
| Device name | Versana Premier, Versana Premier Lotus |
| Reference or catalog number | Versana Premier R3 VA/ 5938559 |
| Model | Versana Premier, Versana Premier Lotus |
| Manufacturer | GE Medical Systems CO. Ltd |
| Manufacturer SRN | CN-MF-000001856 |
| Risk class | Class IIa |
| EMDN code | Z11040101 |
| EMDN description | INTERNAL ULTRASOUND SCANNERS |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Feb 5, 2026 |
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: