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Ulunar Breezhaler

by Novartis Pharma AG

Ref 924569Model Concept1

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7613420000001SQ Basic UDI-DI 47613421040282UDI-DIDate23 Sep 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Breezhaler
Model / Reference
Concept1, 924569
Primary DI / UDI-DI
47613421040282
Basic UDI-DI
7613420000001SQ
Direct Marketing DI
47613421040282
EMDN Code
R03010302 Aerosol portable inhalers
Device Class
Class IIa
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CH-MF-000016941
Authorised representative
Novartis Pharmaceutical Manufacturing GmbH AT-AR-000035391

Other devices from Novartis Pharma AG

See all devices from Novartis Pharma AG →

Properties

  • CMR Substance
  • Administering Medicine
  • Incorporates Medicinal Product

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No