EUDAMED device

Revolution CT ES with Apex edition

EUDAMED device 00195278471277 · GE Medical Systems, LLC

Key facts

Primary DI 00195278471277
Trade name Revolution CT ES with Apex edition
Reference or catalog number Revolution CT ES with Apex edition
Model Apex Edition
Manufacturer GE Medical Systems, LLC
Manufacturer SRN US-MF-000018315
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:

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