Kits / Custom Packs for Non-invasive Ventilation (N.I.V.)

by Hmc Premedical S.P.A. EUDAMED

Active European Union

Ref 600/8013

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number805367629ASSCASCHIQY Basic UDI-DI	Date6 Oct 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name: Kits / Custom Packs for Non-invasive Ventilation (N.I.V.)
Model / Reference: 600/8013

Primary DI / UDI-DI: 08058956300165
Basic UDI-DI: 805367629ASSCASCHIQY
EMDN Code: R0301010402 Niv helmets and kits

Device Class: Class IIa
Medical Purpose: I KIT confezionati da HMC sono KIT per Ventilazione Non Invasiva composti da dispositivi medici destinati al trattamento delle insufficienze respiratorie in modalità non invasiva.

Manufacturer details

EUDAMED SRN: IT-PR-000039107

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Properties

Other properties (1)

Sterile: No