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Kit Mini Well Proxa +21.00D

by SIFI S.p.A. Italy EUDAMED

Ref 1121CCZ

EMDN P030102100202

Regulatory status

as of 24 Oct 2026

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

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
MINI WELL (KIT) and MINI WELL PROXA (KIT)
Model / Reference
1121CCZ
Primary DI / UDI-DI
08027864091984
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

Other devices from SIFI S.p.A.

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Properties & raw data

Show properties, registry sources and raw records
  • Sterile

Sources (1)

  • EUDAMED 34011039-7b61-4f05-aee7-c5d13ffcfbee 61 fields · synced 22 Oct 2026