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Idroflog

by Alfa Intes Industria Terapeutica Splendore S.r.l. 16 variants

Ref 5010123

Active European Union

CE MDR

Valid until

13 Jun 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier ISTITUTO SUPERIORE DI SANITA'

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805848137IDROFLOGMDKU Basic UDI-DI 08058481370213UDI-DIDate8 Jul 2026RegisteredStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • CSQ0023240326 Active Supplemented

    Quality management system EU MDR

    Certifier
    ISTITUTO SUPERIORE DI SANITA' 0373
    Issued
    3 Jul 2026
    Expires
    13 Jun 2029
    Reason
    Add device or group
  • CVD0029240126 Active

    Technical documentation EU MDR

    Certifier
    ISTITUTO SUPERIORE DI SANITA' 0373
    Issued
    3 Jul 2026
    Expires
    13 Jun 2029

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
5010123
Primary DI / UDI-DI
08058481370213
Basic UDI-DI
805848137IDROFLOGMDKU
EMDN Code
Q02030206 Eye lubricant solutions
Device Class
Class III
EU market of registration
Germany

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
  • Incorporates Medicinal Product

Other properties (11)

  • 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