EUDAMED device

Alice PDx Core System without Sensors, INTL

EUDAMED device 00606959039025 · Respironics Inc.

Key facts

Primary DI 00606959039025
Trade name Alice PDx Core System without Sensors, INTL
Device name Alice PDx System
Reference or catalog number 1058370
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 Dec 31, 2024

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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