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

by Hmc Premedical S.P.A. 517 variants

Ref 500/9124

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805367629ASSCASCHIQY Basic UDI-DI 08058956301285UDI-DIDate6 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Kits / Custom Packs for Non-invasive Ventilation (N.I.V.)
Model / Reference
500/9124
Primary DI / UDI-DI
08058956301285
Basic UDI-DI
805367629ASSCASCHIQY
EMDN Code
R0301010401 Cpap 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

Other devices from HMC Premedical S.p.A.

See all devices from HMC Premedical S.p.A. →

Properties

Other properties (1)

  • Sterile: No