EUDAMED device

FastTrack Effort Belt

EUDAMED device 00817377022401 · Dymedix Diagnostics, Inc.

Key facts

Primary DI 00817377022401
Trade name FastTrack Effort Belt
Device name FastTrack
Reference or catalog number 12-41114-0001
Model FastTrack
Manufacturer Dymedix Diagnostics, Inc.
Manufacturer SRN US-MF-000015691
Risk class Class I
EMDN code Z12100585
EMDN description POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES
Legislation mdr
Implantable No
Sterile No
Single use No
Status date Jul 8, 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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