EUDAMED device

REMstar SE with HUMIDIFIER, with SD Slot, INTL

EUDAMED device 00606959036918 · Respironics Inc.

Key facts

Primary DI 00606959036918
Trade name REMstar SE with HUMIDIFIER, with SD Slot, INTL
Device name REMstar, REMstar SE, Dorma
Reference or catalog number IN221HS
Manufacturer Respironics Inc.
Manufacturer SRN US-MF-000002301
Risk class Class IIa
EMDN code Z1203010502
EMDN description ADULT PULMONARY VENTILATORS
Legislation mdd
Implantable No
Sterile No
Single use No
Status date Apr 7, 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:

Browse all EUDAMED devices