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Unodose F1b Gocce oculari (GOF1bM-009)

by Enable Innovations SRL

Ref 050227Model Gocce oculari Innodrops F1b

Active European Union

CE MDR

Valid until

26 Feb 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier ICIM S.P.A.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number80540851202NK Basic UDI-DI 08054085120292UDI-DIDate21 Apr 2026RegisteredStatusActive EUDAMED: not on the EU market

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 0425-MDR-030020-01 Active Supplemented

    Quality management system EU MDR

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Gocce oculari Innodrops F1b
Model / Reference
Gocce oculari Innodrops F1b, 050227
Primary DI / UDI-DI
08054085120292
Basic UDI-DI
80540851202NK
EMDN Code
Q0299 Ophthalmic devices - other
Device Class
Class IIb

Manufacturer details

EUDAMED SRN
IT-MF-000026066

Other devices from Enable Innovations SRL

See all devices from Enable Innovations SRL →

Properties

  • 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