EUDAMED device

FitLife Mask with Headgear, w/SE, Small, INTL

EUDAMED device 00606959023055 · Respironics Inc.

Key facts

Primary DI 00606959023055
Trade name FitLife Mask with Headgear, w/SE, Small, INTL
Device name FitLife Family
Reference or catalog number 1061711
Manufacturer Respironics Inc.
Manufacturer SRN US-MF-000002301
Risk class Class IIa
EMDN code R0301010202
EMDN description NIV MASKS
Legislation mdd
Implantable No
Sterile No
Single use No
Status date Mar 10, 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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