EUDAMED device

Philips Basic Kit, PerformaTrak SE, INTL

EUDAMED device 00606959042551 · Respironics Inc.

Key facts

Primary DI 00606959042551
Trade name Philips Basic Kit, PerformaTrak SE, INTL
Reference or catalog number 1074050
Model PerformaTrak SE Disposable Full Face Mask
Manufacturer Respironics Inc.
Manufacturer SRN US-MF-000002301
Risk class Class IIa
EMDN code Z12062402
EMDN description POSITIONAL BIOFEEDBACK SYSTEMS
Legislation mdd
Implantable No
Sterile No
Single use Yes
Status date Jul 23, 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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