EUDAMED device

System 4 Pro

EUDAMED device 00718175004005 · Biodex Medical Systems

Key facts

Primary DI 00718175004005
Trade name System 4 Pro
Device name Biodex System 4
Reference or catalog number 850-000
Manufacturer Biodex Medical Systems
Manufacturer SRN US-MF-000028834
Risk class Class IIa
EMDN code Z12062680,Z12062692
EMDN description DYNAMOMETRIC SYSTEMS FOR MOVEMENT ANALYSIS - HARDWARE|DYNAMOMETRIC SYSTEMS FOR MOVEMENT ANALYSIS - MEDICAL DEVICE SOFTWARE
Legislation mdr
Implantable No
Sterile No
Single use No
Status date Apr 25, 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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