EUDAMED device

Revolution

EUDAMED device 00198953018996 · GE HANGWEI MEDICAL SYSTEMS CO., LTD.

Key facts

Primary DI 00198953018996
Trade name Revolution
Device name Revolution Altitude Family
Reference or catalog number Revolution Altitude Elite
Manufacturer GE HANGWEI MEDICAL SYSTEMS CO., LTD.
Manufacturer SRN CN-MF-000009292
Risk class Class IIb
EMDN code Z11030605,Z11030606
EMDN description COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS|COMPUTED TOMOGRAPHS - 64 LAYERS OR MORE BUT LESS THAN 128 LAYERS
Legislation mdr
Implantable No
Sterile No
Single use No
Status date Nov 18, 2025

At a glance

  • No 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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