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Medical Oxygen Concentrator

by Shenyang Aerti Tech Co., Ltd. China EUDAMED

Ref AE-3-WModel AE-3,AE-3-S,AE-3-W,AE-5,AE-5-S,AE-5-W,AE-8,AE-8-S,AE-8-W EMDN Z12159004

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number692254670014FJ Basic UDI-DIDate30 Apr 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  • Withdrawn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

Device Name
Medical Oxygen Concentrator
Model / Reference
AE-3, AE-3-S, AE-3-W, AE-5, AE-5-S, AE-5-W, AE-8, AE-8-S, AE-8-W
Primary DI / UDI-DI
06922546700388
Basic UDI-DI
692254670014FJ
Direct Marketing DI
06922546700388
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 9865a624-de76-4f75-a76e-48587b7b7538 61 fields · synced 23 Oct 2026