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Kit Mini Well Toric +09.5SE CL4

by SIFI S.p.A. EUDAMED

Active European Union

Ref X7560CZ

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8027864SIFIMDF35NE Basic UDI-DIDate20 Feb 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
MINI WELL TORIC (KIT) and MINI WELL PROXA TORIC (KIT)
Model / Reference
X7560CZ
Primary DI / UDI-DI
08027864086911
Basic UDI-DI
8027864SIFIMDF35NE
EMDN Code
P030102100302 IOLs, APHAKIC, MULTIFOCAL, TORIC, HYDROPHILIC ACRYLIC
Device Class
Class IIb
Medical Purpose
MINI WELL TORIC and MINI WELL PROXA TORIC intraocular lenses are intended for primary implantation for visual correction of aphakia and pre-existing corneal astigmatism in adults with or without presbyopia after removal of a cataractous lens and aphakia after lensectomy in presbyopic adults with corneal astigmatism who desire increased spectacle independence for distance and near vision.

Manufacturer details

EUDAMED SRN
IT-PR-000021264

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Properties

Show properties
  • Sterile