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Breelib

by Vectura Group Ltd United Kingdom EUDAMED

Ref 08CD1042

EMDN Z12040210

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number50561432BREELIBDP Basic UDI-DIDate8 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Breelib Inhalation System
Model / Reference
08CD1042
Primary DI / UDI-DI
05056143201625
Basic UDI-DI
50561432BREELIBDP
EMDN Code
Z12040210 Ultrasonic nebulisers
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
GB-MF-000029993
Authorised representative
Vectura Ireland Limited IE-AR-000026036

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 7350d9ef-e88f-43eb-a0d4-b09a31ca8791 61 fields · synced 23 Oct 2026