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IOL Mini Well Proxa Toric +30.0SE CL3

by SIFI S.p.A. EUDAMED

Active European Union

Ref 1131CCZ

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  • Withdrawn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 Proxa Toric +30.0SE CL3
IOL Mini Well Proxa Toric +30.0SE CL3.5
Device Name
MINI WELL TORIC (IOL) and MINI WELL PROXA TORIC (IOL)
Model / Reference
1131CCZ
Primary DI / UDI-DI
08027864075137, 08027864075144
Basic UDI-DI
8027864SIFIMDF33NA
Direct Marketing DI
08027864075137
08027864075144
EMDN Code
P030102100302 IOLs, APHAKIC, MULTIFOCAL, TORIC, HYDROPHILIC ACRYLIC
Device Class
Class IIb
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000020853

Other devices from SIFI S.p.A.

See all devices from SIFI S.p.A. →

Properties

Show properties
  • Sterile
  • Implantable
Other properties (12)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Sutures: 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