EUDAMED device

Caption Interpretation

EUDAMED device 00198953038284 · GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Key facts

Primary DI 00198953038284
Trade name Caption Interpretation
Device name Caption Interpretation
Reference or catalog number 5700636
Model 5700636
Manufacturer GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC
Manufacturer SRN US-MF-000016119
Risk class Class IIa
EMDN code Z11040182
EMDN description ULTRASOUND SCANNERS - SOFTWARE ACCESSORIES
Legislation mdr
Implantable No
Sterile No
Single use No
Status date May 28, 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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