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Medical Oxygen Concentrator

by Shenyang Aerti Tech Co., Ltd. China EUDAMED

Ref AR-3-NModel AR-3-N,AR-5-N EMDN Z12159004

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number692254670024FM Basic UDI-DIDate10 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
AR-3-N, AR-5-N
Primary DI / UDI-DI
06922546700166
Basic UDI-DI
692254670024FM
Direct Marketing DI
06922546700166
EMDN Code
Z12159004 Oxygen concentrators
Device Class
Class IIb
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000014272
Authorised representative
Wellkang Ltd XI-AR-000001836

Other devices from Shenyang Aerti Tech Co., Ltd.

See all devices from Shenyang Aerti Tech Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • 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
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 41bc1bf2-5bf2-4ba9-8d73-0974b1ba5c6d 61 fields · synced 23 Oct 2026