EUDAMED device
Revolution Apex Select with Plus Edition
EUDAMED device 00195278788665 · GE HANGWEI MEDICAL SYSTEMS CO., LTD.
Key facts
| Primary DI | 00195278788665 |
|---|---|
| Trade name | Revolution Apex Select with Plus Edition |
| Device name | Revolution Apex Select |
| Reference or catalog number | Revolution Apex Select with Plus Edition |
| Manufacturer | GE HANGWEI MEDICAL SYSTEMS CO., LTD. |
| Manufacturer SRN | CN-MF-000009292 |
| Risk class | Class IIb |
| EMDN code | Z11030607 |
| EMDN description | COMPUTED TOMOGRAPHS - 256 LAYERS OR MORE |
| 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: