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Kit Mini Well Proxa +24.50D

by SIFI S.p.A.

Ref 1121CCZ

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8027864SIFIMDF25NB Basic UDI-DI 08027864092059UDI-DIDate20 Feb 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
MINI WELL (KIT) and MINI WELL PROXA (KIT)
Model / Reference
1121CCZ
Primary DI / UDI-DI
08027864092059
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