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Lacriben (GOBBP-006)

by Enable Innovations SRL Italy EUDAMED

Ref 050113Model Gocce oculari Innodrops BB EMDN Q0299

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number80540851204NP 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  • Withdrawn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 · synced 25 Oct 2026

Device Name
Gocce oculari Innodrops BB
Model / Reference
Gocce oculari Innodrops BB, 050113
Primary DI / UDI-DI
08054085120766
Basic UDI-DI
80540851204NP
EMDN Code
Q0299 Ophthalmic devices - other
Device Class
Class IIb
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000026066

Other devices from Enable Innovations SRL

See all devices from Enable Innovations SRL →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 7772e7c1-4395-422d-a8a7-1fd84ac0588b 61 fields · synced 25 Oct 2026