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Kit Mini Well Proxa +13.50D

by SIFI S.p.A. EUDAMED

Active European Union

Ref 1121CCZ

Overview

The KIT MINI WELL PROXA +13.50D device is a Class IIb medical device designed for the implantation of intraocular lenses, particularly suitable for patients with or without presbyopia after cataract removal and aphakia following refractive lensectomy. This device provides excellent vision correction for distance and near vision.

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8027864SIFIMDF25NB Basic UDI-DIDate20 Feb 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

No EU certificate is linked to this device in EUDAMED.

Specification

EUDAMED

Device Name
MINI WELL (KIT) and MINI WELL PROXA (KIT)
Model / Reference
1121CCZ
Primary DI / UDI-DI
08027864091830
Basic UDI-DI
8027864SIFIMDF25NB
EMDN Code
P030102100202 IOLs, APHAKIC, MULTIFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC
Device Class
Class IIb
Medical Purpose
MINI WELL and MINI WELL PROXA intraocular lenses are intended for primary implantation for visual correction of aphakia in adult patients with or without presbyopia after removal of a cataractous lens and of aphakia after refractive lensectomy in presbyopic adults who desire increased spectacle independence for distance and near vision.

Manufacturer details

EUDAMED SRN
IT-PR-000021264

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Properties

  • Sterile