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Disposable Oxygen Mask

by Jiangsu Hanbo Medical Equipment Co., Ltd. EUDAMED

Withdrawn Not intended for the EU market

Ref Adult-L-01Model Adult-S-01（sterile）

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697551916OM56 Basic UDI-DIDate23 Nov 2025RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
Adult-S-01（sterile）, Adult-L-01
Primary DI / UDI-DI
06975519160412
Basic UDI-DI
697551916OM56
EMDN Code
R03010201 Air/oxygen masks
Device Class
Class IIa

Manufacturer details

EUDAMED SRN
CN-MF-000027198
Authorised representative
Lotus NL B.V. NL-AR-000000121

Properties

Show properties
  • Sterile
Other properties (12)
  • 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