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oxygen concentrator

by Awatar Medical Aid d.o.o. Croatia EUDAMED

Ref AW OXC001 10.SModel Pulmocare

EMDN Z12159004

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number385889357AWOX0016J Basic UDI-DIDate13 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
oxygen concentrator
Model / Reference
Pulmocare, AW OXC001 10.S
Primary DI / UDI-DI
03858893574767
Basic UDI-DI
385889357AWOX0016J
Direct Marketing DI
03858893574767
EMDN Code
Z12159004 Oxygen concentrators
Device Class
Class IIa
Market of Registration
Croatia

Manufacturer details

EUDAMED SRN
HR-MF-000025777

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 7f17d71e-cff4-4a75-a340-de3dcd8dfd7e 61 fields · synced 22 Oct 2026