EUDAMED device

Alice 5 International Headbox

EUDAMED device 00606959020375 · Respironics Inc.

Key facts

Primary DI 00606959020375
Trade name Alice 5 International Headbox
Device name Alice 5 and Alice LE Polysomnography Systems
Reference or catalog number 1017231
Model 1017231
Manufacturer Respironics Inc.
Manufacturer SRN US-MF-000002301
Risk class Class IIa
EMDN code Z12100501
EMDN description POLYSOMNOGRAPHS
Legislation mdd
Implantable No
Sterile No
Single use No
Status date Aug 18, 2025

At a glance

  • No 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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