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Ophthalmic 1.67 Progressive Addition Photochromic Lens

by Tokai Optical Co., Ltd,

Model Organic Progressive Ophthalmic lens

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4550543Pl1.67PalPhotoPE Basic UDI-DI 04550543014218UDI-DIDate25 Dec 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
Organic Progressive Ophthalmic lens
Primary DI / UDI-DI
04550543014218
Basic UDI-DI
4550543Pl1.67PalPhotoPE
EMDN Code
Q0210010103 Progressive organic ophthalmic lenses
Device Class
Class I
EU market of registration
Belgium

Manufacturer details

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

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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