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Aerogen Ultra Mouthpiece 10 Pack

by Aerogen Ltd EUDAMED

Active European Union

Ref AG-AS7003Model AG-AS7000-EUR

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number539151793AG00013WH Basic UDI-DIDate14 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  • Withdrawn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

Device Name
Aerogen Ultra
Model / Reference
AG-AS7000-EUR, AG-AS7003
Primary DI / UDI-DI
05391517938258
Basic UDI-DI
539151793AG00013WH
EMDN Code
R060101 Cold nebulisation systems
Device Class
Class IIa
Market of Registration
Bulgaria

Manufacturer details

EUDAMED SRN
IE-MF-000004597

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Properties

Show 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