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Ophthalmic 1.60 Bifocal Clear Lens

by Tokai Optecs NV Belgium EUDAMED

Ref N/AModel Mineral Ophthalmic Lens, Organic Bifocal Clear Lens

EMDN Q0210010202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5401116GL160BFCLZK Basic UDI-DIDate6 Sep 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
Mineral Ophthalmic Lens, N/A, Organic Bifocal Clear Lens
Primary DI / UDI-DI
05401116034005, 05401116134002
Basic UDI-DI
5401116GL160BFCLZK, 5401116PL160BFCL85
EMDN Code
Q0210010202, Q0210010102
Device Class
Class I
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000003303

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See all devices from Tokai Optecs NV →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (2)

  • EUDAMED 7e7c241f-0de3-4666-95ba-bc12d1960466 61 fields · synced 22 Oct 2026
  • EUDAMED 05401116134002|5401116PL160BFCL85 61 fields · synced 19 May 2026