Skip to content

Medical Oxygen Concentrator

by Shenyang Aerti Tech Co., Ltd. China EUDAMED

Ref AE-5-NWModel AE-3-N,AE-3-NW,AE-5-N,AE-5-NW,AE-8-N,AE-8-NW EMDN Z12159004

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number692254670015FL 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  • Withdrawn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 22 Oct 2026

Device Name
Medical Oxygen Concentrator
Model / Reference
AE-3-N, AE-3-NW, AE-5-N, AE-5-NW, AE-8-N, AE-8-NW
Primary DI / UDI-DI
06922546700111
Basic UDI-DI
692254670015FL
Direct Marketing DI
06922546700111
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 f7fd297a-f562-423a-9918-4aab8cddacf2 61 fields · synced 22 Oct 2026