EUDAMED device
Definium Tempo Pro
EUDAMED device 00195278070265 · GE HUALUN MEDICAL SYSTEMS CO. Ltd
Key facts
| Primary DI | 00195278070265 |
|---|---|
| Trade name | Definium Tempo Pro |
| Device name | Medical Diagnostic Radiology Device |
| Reference or catalog number | B2402CAB |
| Model | Definium Tempo Pro |
| Manufacturer | GE HUALUN MEDICAL SYSTEMS CO. Ltd |
| Manufacturer SRN | CN-MF-000001189 |
| Risk class | Class IIb |
| EMDN code | Z11031101 |
| EMDN description | MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY|SISTEMI POLIFUNZIONALI PER RADIOLOGIA DIGITALE DIRETTA (DR)|SYSTÈMES POLYVALENTS DE RADIOGRAPHIE NUMÉRIQUE DIRECTE (DR) |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Jan 27, 2022 |
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: