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Welllead Mesh Nebulizer Kit

by Well Lead Medical Co., Ltd. China EUDAMED

Ref R01L021230Model AeroTank Kit EMDN R03010304

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69449327FR01E04KP Basic UDI-DIDate10 Jun 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  • Withdrawn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
Mesh Nebulizer Kit
Model / Reference
AeroTank Kit, R01L021230
Primary DI / UDI-DI
06925816654831
Basic UDI-DI
69449327FR01E04KP
EMDN Code
R03010304 Aerosol therapy kits
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000006728
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Well Lead Medical Co., Ltd

See all devices from Well Lead Medical Co., Ltd →

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 b7e17c25-dedd-477b-b426-d20b6cd207f1 61 fields · synced 24 Oct 2026