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Oftaial

by Alfa Intes Industria Terapeutica Splendore S.r.l. 2 variants

Ref 599

Active European Union

CE MDR

Valid until

12 May 2031

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805848137OFTAIALW8 Basic UDI-DI 08058481370121UDI-DIDate26 Jun 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 0425-MDR-030191-00 Active

    Quality management system EU MDR

    Certifier
    ICIM S.P.A. 0425
    Issued
    13 May 2026
    Expires
    12 May 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
599
Primary DI / UDI-DI
08058481370121
Basic UDI-DI
805848137OFTAIALW8
EMDN Code
Q02030206 Eye lubricant solutions
Device Class
Class IIb
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000025980

Other devices from Alfa Intes Industria Terapeutica Splendore S.r.l.

  • Idroflog

    Class III

  • Oftaial

    Class IIb

  • Oftaial Plus

    Class IIb

  • Idroflog

    Class III

  • Idroflog

    Class III

  • Oftaial Plus

    Class IIb

See all devices from Alfa Intes Industria Terapeutica Splendore S.r.l. →

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