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Aerosol Masks

by Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. EUDAMED

Active European Union

Ref HAI11-EModel nebulizer mask

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697030431220600139F Basic UDI-DIDate21 Apr 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  • Withdrawn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

Device Name
Aerosol Masks
Model / Reference
nebulizer mask, HAI11-E
Primary DI / UDI-DI
06970304312748
Basic UDI-DI
697030431220600139F
EMDN Code
R03010301 Aerosol therapy masks
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000002179
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd.

See all devices from Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. →

Properties

  • Administering Medicine

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
  • Measuring Function: No
  • Incorporates Medicinal Product: No