EUDAMED device

Ultium EMG Biofeedback App

EUDAMED device 00816271020766 · Noraxon USA, Inc.

Key facts

Primary DI 00816271020766
Trade name Ultium EMG Biofeedback App
Device name Wireless EMG Family Accessories
Reference or catalog number APP01
Manufacturer Noraxon USA, Inc.
Manufacturer SRN US-MF-000003882
Risk class Class I
EMDN code Z12062482
EMDN description BIOFEEDBACK INSTRUMENTS - SOFTWARE ACCESSORIES
Legislation mdr
Implantable No
Sterile No
Single use No
Status date Jul 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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