EUDAMED device
Revolution Apex Select
EUDAMED device 00195278469700 · GE HANGWEI MEDICAL SYSTEMS CO., LTD.
Key facts
| Primary DI | 00195278469700 |
|---|---|
| Trade name | Revolution Apex Select |
| Device name | Revolution Apex Select |
| Reference or catalog number | Power Xtream: B7919QT; Power Pro: B7919QS |
| Manufacturer | GE HANGWEI MEDICAL SYSTEMS CO., LTD. |
| Manufacturer SRN | CN-MF-000009292 |
| Risk class | Class IIb |
| EMDN code | Z11030606 |
| EMDN description | COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Aug 20, 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: