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Ophthalmic 1.50 Bifocal Lens

by Tokai Optical Co., Ltd, EUDAMED

Active European Union

Model Organic Multifocal Ophthalmic lens

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4550543Pl1.50BifClear48 Basic UDI-DIDate25 Dec 2025RegisteredStatusActive

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  • Withdrawn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 Multifocal Ophthalmic lens
Primary DI / UDI-DI
04550543015000
Basic UDI-DI
4550543Pl1.50BifClear48
EMDN Code
Q0210010102 Multifocal organic ophthalmic lenses (bifocal, trifocal)
Device Class
Class I
Market of Registration
Belgium

Manufacturer details

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

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Properties

Show 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