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Disposable Nebulizer Mask

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

Ref Pediatric-L-8-01Model Adult-S-6-01（sterile） EMDN R03010301

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697551916NK4X Basic UDI-DIDate24 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  • Withdrawn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European Union — CE/MDR Withdrawn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 · synced 25 Oct 2026

Model / Reference
Adult-S-6-01（sterile）, Pediatric-L-8-01
Primary DI / UDI-DI
16975519160518
Basic UDI-DI
697551916NK4X
EMDN Code
R03010301 Aerosol therapy masks
Device Class
Class IIa

Manufacturer details

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

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED e455657d-a7d1-4783-9a85-306e31037316 61 fields · synced 25 Oct 2026