EUDAMED device

Quality Care Suite 2.0

EUDAMED device 00195278584441 · GE Medical Systems, LLC

Key facts

Primary DI 00195278584441
Trade name Quality Care Suite 2.0
Device name Quality Care Suite
Reference or catalog number S3003CV, S3003EV
Model Quality Care Suite
Manufacturer GE Medical Systems, LLC
Manufacturer SRN US-MF-000018315
Risk class Class I
EMDN code Z11039092
EMDN description VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - MEDICAL DEVICE SOFTWARE
Legislation mdr
Implantable No
Sterile No
Single use No
Status date Sep 26, 2023

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)

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