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PRECIZON Toric

by Ophtec BV 1,000+ variants

Ref 56506TY45Model 565

Expiring European Union

CE MDR

Valid until

1 Nov 2027

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier DEKRA Certification B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8717819Precizon565/6S Basic UDI-DI 08717819119275UDI-DIDate22 Jun 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2254207TD01 Expiring Supplemented Expires in 362 days

    Technical documentation EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    12 Jun 2025
    Expires
    1 Nov 2027
    Reason
    Add device or group

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Expiring

Specification

EUDAMED

Device Name
PRECIZON Toric
Model / Reference
565, 56506TY45
Primary DI / UDI-DI
08717819119275
Basic UDI-DI
8717819Precizon565/6S
EMDN Code
P030102090302 IOLs, APHAKIC, MONOFOCAL, TORIC, HYDROPHILIC ACRYLIC
Device Class
Class IIb
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000000048

Other devices from Ophtec BV

See all devices from Ophtec BV →

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