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DiVial Plus (GOF1bM-004)

by Enable Innovations SRL EUDAMED

Active European Union

Ref 050075Model Gocce oculari Innodrops F1b

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number80540851202NK Basic UDI-DIDate21 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  • Withdrawn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-030020-01 Supplemented

    Quality management system EU MDR

    Notified body
    ICIM S.P.A. 0425
    Issued
    26 Mar 2025
    Expires
    26 Feb 2028
    Reason
    Other

Specification

EUDAMED

Device Name
Gocce oculari Innodrops F1b
Model / Reference
Gocce oculari Innodrops F1b, 050075
Primary DI / UDI-DI
08054085120421
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000026066

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