EUDAMED device

Ultium EMG Sensor Tape

EUDAMED device 00816271020391 · Noraxon USA, Inc.

Key facts

Primary DI 00816271020391
Trade name Ultium EMG Sensor Tape
Device name Wireless EMG Family Accessories
Reference or catalog number 810C
Manufacturer Noraxon USA, Inc.
Manufacturer SRN US-MF-000003882
Risk class Class I
EMDN code Z12100485
EMDN description ELECTROMYOGRAPHY INSTRUMENTS - CONSUMABLES
Legislation mdr
Implantable No
Sterile No
Single use Yes
Status date Feb 21, 2024

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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