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Disposable Oxygen Mask

by Jiangsu Hanbo Medical Equipment Co., Ltd. China EUDAMED

Ref Adult-S-02(non sterile)Model Adult-S-01(non sterile)

EMDN R03010201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697551916OMNSTQ Basic UDI-DIDate21 Nov 2025RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Withdrawn
  • Not covered

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
Adult-S-01(non sterile), Adult-S-02(non sterile)
Primary DI / UDI-DI
16975519160914
Basic UDI-DI
697551916OMNSTQ
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

Other devices from Jiangsu Hanbo Medical Equipment Co., Ltd.

See all devices from Jiangsu Hanbo Medical Equipment 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 4276115e-238b-4fef-89ff-a8cc533c0781 61 fields · synced 24 Oct 2026