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Aplus Humidification Chamber

by GaleMed (Xiamen) Co., Ltd. China EUDAMED

Ref XJK0001

EMDN R060280

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69239801ND2FANV Basic UDI-DIDate11 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Disposable Humidification Chamber
Model / Reference
XJK0001
Primary DI / UDI-DI
16923980105712
Basic UDI-DI
69239801ND2FANV
EMDN Code
R060280 Humidification systems - accessories
Device Class
Class IIa
Market of Registration
Cyprus

Manufacturer details

EUDAMED SRN
CN-MF-000020627
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from GaleMed (Xiamen) Co., Ltd.

See all devices from GaleMed (Xiamen) Co., Ltd. →

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 16923980105712|69239801ND2FANV 61 fields · synced 24 Oct 2026