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Ophthalmic 1.60 Single Vision Clear Lens

by Tokai Optecs NV EUDAMED

Active European Union

Model Organic Single Vision Ophthalmic Lens, Mineral Ophthalmic Lens

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5401116PL160SVCLEC Basic UDI-DIDate5 Sep 2023RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
Organic Single Vision Ophthalmic Lens, Mineral Ophthalmic Lens
Primary DI / UDI-DI
05401116132008, 05401116031004
Basic UDI-DI
5401116PL160SVCLEC, 5401116GL160SVCL7V
EMDN Code
Q0210010101, Q0210010201
Device Class
Class I
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000003303

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Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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