EUDAMED device

Enterprise Archive version 8

EUDAMED device 00195278409287 · GE Healthcare

Key facts

Primary DI 00195278409287
Trade name Enterprise Archive version 8
Device name Centricity Enterprise Archive/Enterprise Archive
Reference or catalog number K2048AED
Manufacturer GE Healthcare
Manufacturer SRN US-MF-000001862
Risk class Class I
EMDN code Z11030592
EMDN description RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
Legislation mdr
Implantable No
Sterile No
Single use No
Status date Feb 2, 2026

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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