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Non-Invasive Ventilation Device

by Phoenix Medical Systems Pvt. Ltd India EUDAMED

Ref Cat.No: 7.2.3- 46Model HavenHood EMDN R0301010402

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number890603394A140900RP Basic UDI-DIDate18 Jul 2026RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Non-Invasive Ventilation Device
Model / Reference
HavenHood, Cat.No: 7.2.3- 46
Primary DI / UDI-DI
08906033940097
Basic UDI-DI
890603394A140900RP
EMDN Code
R0301010402 Niv helmets and kits
Device Class
Class I

Manufacturer details

EUDAMED SRN
IN-MF-000022931
Authorised representative
Obelis s.a. BE-AR-000000106

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Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED a8600670-3273-4e75-9e0a-b4058a5fb87b 61 fields · synced 23 Oct 2026