EUDAMED device
SIGNA Premier
EUDAMED device 00195278010797 · GE Medical Systems LLC
Key facts
| Primary DI | 00195278010797 |
|---|---|
| Trade name | SIGNA Premier |
| Device name | SIGNA Premier |
| Reference or catalog number | SIGNA Premier |
| Model | SIGNA Premier |
| Manufacturer | GE Medical Systems LLC |
| Manufacturer SRN | US-MF-000001632 |
| Risk class | Class IIa |
| EMDN code | Z11050105 |
| EMDN description | CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD GREATER THAN 2T AND LESS THAN OR EQUAL TO 4T |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Oct 30, 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: