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Neonatal CPAP unit

by Phoenix Medical Systems Pvt. Ltd India EUDAMED

Ref 7.2.3‐31Model nCPAP300 EMDN Z12030102

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08906033940110 Basic UDI-DIDate8 Sep 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Neonatal CPAP unit
Model / Reference
nCPAP300, 7.2.3‐31
Primary DI / UDI-DI
08906033940110
Basic UDI-DI
B-08906033940110
EMDN Code
Z12030102 Continuous positive pressure equipment
Device Class
Class IIb
Market of Registration
Austria

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 (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 89ac011e-cf7a-4106-8dbb-fb97579ded61 61 fields · synced 22 Oct 2026