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Evolux +19.50D

by SIFI S.p.A. Italy EUDAMED

Ref 1110ACHModel 1110ACHPXXXXB

EMDN P030102090201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8027864SIFIMDF40N7 Basic UDI-DIDate24 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • 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 · synced 24 Oct 2026

Device Name
Evolux
Model / Reference
1110ACHPXXXXB, 1110ACH
Primary DI / UDI-DI
08027864097016
Basic UDI-DI
8027864SIFIMDF40N7
Direct Marketing DI
08027864097016
EMDN Code
P030102090201 IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHOBIC ACRYLIC
Device Class
Class IIb
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000020853

Other devices from SIFI S.p.A.

See all devices from SIFI S.p.A. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 08027864097016|8027864SIFIMDF40N7 61 fields · synced 24 Oct 2026