EUDAMED device

CASE

EUDAMED device 00195278403643 · GE Medical Systems Information Technologies, Inc.

Key facts

Primary DI 00195278403643
Trade name CASE
Reference or catalog number 2035123-001
Model CASE V7.0
Manufacturer GE Medical Systems Information Technologies, Inc.
Manufacturer SRN US-MF-000017529
Risk class Class IIa
EMDN code Z12050301
EMDN description GENERAL PURPOSE ELECTROCARDIOGRAPHS
Legislation mdr
Implantable No
Sterile No
Single use No
Status date Jun 8, 2022

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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