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IOL Mini Well Proxa Toric +26.5SE CL3.5

by SIFI S.p.A.

Ref 1131CCZ

Active European Union

CE MDR

Valid until

31 Aug 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier ITALCERT SRL

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Overview

The IOL MINI WELL PROXA TORIC +26.5SE CL3.5 medical device is a type of intraocular lens designed to provide excellent vision for patients with cataracts or other eye conditions. This device features a small, implantable lens that can be placed on the natural lens of the eye, allowing patients to see clearly and comfortably.

Regulatory status

as of registry sync 24 Oct 2026

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

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 028-00-04-MDR Active Supplemented

    Technical documentation EU MDR

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Trade Name
IOL Mini Well Proxa Toric +26.5SE CL3.5
IOL Mini Well Proxa Toric +26.5SE CL3
Device Name
MINI WELL TORIC (IOL) and MINI WELL PROXA TORIC (IOL)
Model / Reference
1131CCZ
Primary DI / UDI-DI
08027864074581, 08027864074574
Basic UDI-DI
8027864SIFIMDF33NA
Direct Marketing DI
08027864074581
08027864074574
EMDN Code
P030102100302 IOLs, APHAKIC, MULTIFOCAL, TORIC, HYDROPHILIC ACRYLIC
Device Class
Class IIb
EU 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

  • 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