Skip to content

Kit IOL Mini 4 Ready +26.50D

by SIFI S.p.A. EUDAMED

Active European Union

Ref S7560CZModel S7560CZP00003

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8027864SIFIMDF03MZ Basic UDI-DIDate14 Sep 2026RegisteredStatusActive

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  • Withdrawn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
Kit IOL Mini 4 Ready +26.50D
IOL Mini 4 Ready +26.50D
Device Name
Mini 4 Ready (Kit)
Mini 4 Ready (IOL)
Model / Reference
S7560CZ, S7560CZP00003
Primary DI / UDI-DI
08027864082708, 08027864061956
Basic UDI-DI
8027864SIFIMDF03MZ, 8027864SIFIMDF37NJ
Direct Marketing DI
08027864061956
EMDN Code
P030102090202 IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC
Device Class
Class IIb
Market of Registration
Italy
Medical Purpose
MINI 4 Ready aspheric IOLs are intended for primary implantation for visual correction of aphakia in adult patients (≥ 18 years old) after removal of a cataractous lens. These implants must be positioned within the capsular bag.

Manufacturer details

EUDAMED SRN
IT-PR-000021264

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