EUDAMED device
SmartMAR
EUDAMED device 00195278303219 · GE Healthcare Japan Corporation
Key facts
| Primary DI | 00195278303219 |
|---|---|
| Trade name | SmartMAR |
| Device name | SmartMAR |
| Reference or catalog number | 5869274 |
| Manufacturer | GE Healthcare Japan Corporation |
| Manufacturer SRN | JP-MF-000009291 |
| Risk class | Class IIa |
| EMDN code | Z11030692 |
| EMDN description | COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Aug 7, 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: