EUDAMED device
SIGNA Prime Elite
EUDAMED device 00195278601162 · GE Healthcare Tianjin Company Limited
Key facts
| Primary DI | 00195278601162 |
|---|---|
| Trade name | SIGNA Prime Elite |
| Device name | SIGNA Prime Elite |
| Reference or catalog number | SIGNA Prime Elite |
| Model | SIGNA Prime Elite |
| Manufacturer | GE Healthcare Tianjin Company Limited |
| Manufacturer SRN | CN-MF-000001725 |
| Risk class | Class IIa |
| EMDN code | Z11050104 |
| EMDN description | CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Oct 29, 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: