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Spacer for Aerosol

by Ningbo Luke Medical Devices Co., LTD China EUDAMED

Ref ICA-012Model Spacer for Aerosol EMDN R0699

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697024089SAY9 Basic UDI-DIDate19 May 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  • Withdrawn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 · synced 24 Oct 2026

Device Name
Spacer for Aerosol
Model / Reference
Spacer for Aerosol, ICA-012
Primary DI / UDI-DI
06970240895886
Basic UDI-DI
697024089SAY9
Direct Marketing DI
06970240895886
EMDN Code
R0699 Nebulisation and humidification systems - other
Device Class
Class IIa
Market of Registration
Estonia

Manufacturer details

EUDAMED SRN
CN-MF-000011732
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Ningbo Luke Medical Devices Co., LTD

See all devices from Ningbo Luke Medical Devices 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 5758a30d-1019-4d05-b01a-db198678ef76 61 fields · synced 24 Oct 2026