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FLUIStar A (S1-001)

by Enable Innovations SRL EUDAMED

Active European Union

Ref 050450Model Soluzione inalatoria S1

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number80540851208NX Basic UDI-DIDate8 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 0425-MDR-030179-00 Issued

    Quality management system EU MDR

    Notified body
    ICIM S.P.A. 0425
    Issued
    23 Mar 2026
    Expires
    22 Mar 2031

Specification

EUDAMED

Device Name
Soluzione inalatoria S1
Model / Reference
Soluzione inalatoria S1, 050450
Primary DI / UDI-DI
08054085121732
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000026066

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