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IOL Mini Well Toric +16.0SE CL4

by SIFI S.p.A. EUDAMED

Active European Union

Ref X7560CZ

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number028-00-04-MDR Date1 Sep 2026IssuedStatusActive expires 31 Aug 2028

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  • Withdrawn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)
  • 028-00-04-MDR Supplemented

    Technical documentation EU MDR

    Notified body
    ITALCERT SRL 0426
    Issued
    1 Sep 2026
    Expires
    31 Aug 2028
    Reason
    Add device or group

Specification

EUDAMED

Trade Name
IOL Mini Well Toric +16.0SE CL4
IOL Mini Well Toric +16.0SE CL4.5
Device Name
MINI WELL TORIC (IOL) and MINI WELL PROXA TORIC (IOL)
Model / Reference
X7560CZ
Primary DI / UDI-DI
08027864067200, 08027864067217
Basic UDI-DI
8027864SIFIMDF33NA
Direct Marketing DI
08027864067200
08027864067217
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000020853

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