EUDAMED device

TriplePlay Airflow

EUDAMED device 00817377020001 · Dymedix Diagnostics, Inc.

Key facts

Primary DI 00817377020001
Trade name TriplePlay Airflow
Device name TriplePlan Airflow
Reference or catalog number 10-10000-0001
Model TriplePlay Airflow Sensors
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 Yes
Status date May 30, 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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