EUDAMED device

System One Heated Humidifier INTL

EUDAMED device 00606959014244 · Respironics Inc.

Key facts

Primary DI 00606959014244
Trade name System One Heated Humidifier INTL
Reference or catalog number IN6H
Model System One Heated Humidifier
Manufacturer Respironics Inc.
Manufacturer SRN US-MF-000002301
Risk class Class IIa
EMDN code R060201
EMDN description ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,
Legislation mdd
Implantable No
Sterile No
Single use No
Status date Jul 18, 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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