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Osmotears Low OS 280 (OS280-001)

by Enable Innovations SRL EUDAMED

Active European Union

Ref 050205Model Goccia oculare Osmotears Low 280

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number80540851220NM Basic UDI-DIDate15 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  • Withdrawn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-030119-01 Supplemented

    Quality management system EU MDR

    Notified body
    ICIM S.P.A. 0425
    Issued
    25 Feb 2026
    Expires
    2 Feb 2030
    Reason
    Add device or group

Specification

EUDAMED

Device Name
Goccia oculare Osmotears Low 280
Model / Reference
Goccia oculare Osmotears Low 280, 050205
Primary DI / UDI-DI
08054085120643
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
IT-MF-000026066

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