EUDAMED device
MyoSPECT ES to MyoSPECT Upgrade
EUDAMED device 00195278722546 · GE Medical Systems Israel", Functional Imaging
Key facts
| Primary DI | 00195278722546 |
|---|---|
| Trade name | MyoSPECT ES to MyoSPECT Upgrade |
| Device name | MyoSPECT |
| Reference or catalog number | H3912BS |
| Model | MyoSPECT |
| Manufacturer | GE Medical Systems Israel", Functional Imaging |
| Manufacturer SRN | IL-MF-000003062 |
| Risk class | Class IIa |
| EMDN code | Z11020104 |
| EMDN description | FIXED STATION GAMMA CAMERAS WITH MULTIPLE HEADS - WITHOUT ‘TOTAL BODY’ ACQUISITION |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Jan 12, 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: