EUDAMED device
1.5T HDxt Upgrade Kit
EUDAMED device 00195278416339 · GE Medical Systems LLC
Key facts
| Primary DI | 00195278416339 |
|---|---|
| Trade name | 1.5T HDxt Upgrade Kit |
| Device name | 1.5T HDxt Upgrade Kit |
| Reference or catalog number | 1.5T HDxt Upgrade Kit |
| Model | 1.5T HDxt Upgrade Kit |
| Manufacturer | GE Medical Systems LLC |
| Manufacturer SRN | US-MF-000001632 |
| 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 28, 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: