EUDAMED device

Revolution Advance

EUDAMED device 00195278385215 · GE HANGWEI MEDICAL SYSTEMS CO., LTD.

Key facts

Primary DI 00195278385215
Trade name Revolution Advance
Device name Revolution Advance
Reference or catalog number Revolution Advance
Manufacturer GE HANGWEI MEDICAL SYSTEMS CO., LTD.
Manufacturer SRN CN-MF-000009292
Risk class Class IIb
EMDN code Z11030603
EMDN description COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 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:

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