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PRECIZON Presbyopic Toric

by Ophtec BV United States EUDAMED

Ref 575A109TY48Model 575

EMDN P030102100302

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8717819Precizon575/6X Basic UDI-DIDate21 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2254207TD01 Supplemented

    Technical documentation EU MDR

    Notified body
    Notified body 0344
    Issued
    12 Jun 2025
    Expires
    1 Nov 2027
    Reason
    Add device or group

Specification

EUDAMED · synced 23 Oct 2026

Device Name
PRECIZON Presbyopic Toric
Model / Reference
575, 575A109TY48
Primary DI / UDI-DI
08717819152869
Basic UDI-DI
8717819Precizon575/6X
EMDN Code
P030102100302 IOLs, APHAKIC, MULTIFOCAL, TORIC, HYDROPHILIC ACRYLIC
Device Class
Class IIb
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000000048

Other devices from Ophtec BV

See all devices from Ophtec BV →

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 08717819152869|8717819PRECIZON575/6X 61 fields · synced 23 Oct 2026