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Torica-aXA 29.5 cyl+3.0

by HumanOptics Holding AG EUDAMED

Active European Union

Ref 00041300

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number04049154_PC_M2_H4_O3_CM Basic UDI-DIDate5 Nov 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 44911221836 Supplemented

    Quality management system EU MDR

    Notified body
    Notified body 0044
    Issued
    10 Jun 2026
    Expires
    12 Jun 2030
    Reason
    Other
  • 44912221836 Supplemented

    Technical documentation EU MDR

    Notified body
    Notified body 0044
    Issued
    10 Jun 2026
    Expires
    12 Jun 2030
    Reason
    Other

Specification

EUDAMED

Device Name
IOLs, aphakic / Family Torica-aXA/Y
Model / Reference
00041300
Primary DI / UDI-DI
04049154365098
Basic UDI-DI
04049154_PC_M2_H4_O3_CM
EMDN Code
P030102090302 IOLs, APHAKIC, MONOFOCAL, TORIC, HYDROPHILIC ACRYLIC
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000017892

Other devices from HumanOptics Holding AG

See all devices from HumanOptics Holding AG →

Properties

Show properties
  • 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