Skip to content

Oftassiale

by Drugs Minerals and Generics Italia S.r.l. Italy EUDAMED

Ref 80OFT003MModel Soluzione Oftalmica Protezione Corneale

EMDN Q0299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number803412518TF336Z Basic UDI-DIDate22 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • EPT 0477.MDR.24/5448 Issued

    Quality management system EU MDR

    Notified body
    Notified body 0477
    Issued
    12 Apr 2024
    Expires
    11 Apr 2029

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
Soluzione Oftalmica Protezione Corneale, 80OFT003M
Primary DI / UDI-DI
08034125186747
Basic UDI-DI
803412518TF336Z
EMDN Code
Q0299 Ophthalmic devices - other
Device Class
Class IIb
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000024945

Other devices from Drugs Minerals and Generics Italia S.r.l.

See all devices from Drugs Minerals and Generics Italia S.r.l. →

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 08034125186747|803412518TF336Z 61 fields · synced 24 Oct 2026