EUDAMED device

Ultium Sports Glove (L/XL)

EUDAMED device 00816271020865 · Noraxon USA, Inc.

Key facts

Primary DI 00816271020865
Trade name Ultium Sports Glove (L/XL)
Device name Wireless IMU Family Accessories
Reference or catalog number 874 GLL, GLR
Manufacturer Noraxon USA, Inc.
Manufacturer SRN US-MF-000003882
Risk class Class I
EMDN code Z12062599
EMDN description KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - OTHER
Legislation mdr
Implantable No
Sterile No
Single use No
Status date Jul 11, 2025

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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