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1.67Bi-AS UV

by Tokai Optical Co., Ltd, Japan EUDAMED

Ref N/AModel Organic Monofocal Ophthalmic lens

EMDN Q0210010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4960682Pl1.67SvClearZJ Basic UDI-DIDate24 Dec 2025RegisteredStatusActive

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
Organic Monofocal Ophthalmic lens, N/A
Primary DI / UDI-DI
04960682013810
Basic UDI-DI
4960682Pl1.67SvClearZJ
EMDN Code
Q0210010101 Monofocal organic ophthalmic lenses
Device Class
Class I
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
JP-MF-000024672
Authorised representative
Tokai Optecs NV BE-AR-000024178

Other devices from Tokai Optical Co., Ltd,

See all devices from Tokai Optical Co., Ltd, →

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 (1)

  • EUDAMED 2433cd86-b075-47de-95ea-098a9acf90bd 61 fields · synced 22 Oct 2026