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Sekai

by Hana International Ltd. South Korea EUDAMED

Ref SK-1.60 MR8 AS-CLModel SEKAI EMDN Q0210010101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number56006822552SEKAISVJR Basic UDI-DIDate27 Apr 2026RegisteredStatusActive

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  • Withdrawn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 · synced 22 Oct 2026

Device Name
Platinum / Blue Core Series
Model / Reference
SEKAI, SK-1.60 MR8 AS-CL
Primary DI / UDI-DI
05600682255221
Basic UDI-DI
56006822552SEKAISVJR
EMDN Code
Q0210010101 Monofocal organic ophthalmic lenses
Device Class
Class I
Market of Registration
Portugal

Manufacturer details

EUDAMED SRN
KR-MF-000053144
Authorised representative
FUKUJIN CORP, UNIPESSOAL LDA PT-AR-000052025

Other devices from Hana International 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 a321303a-a5f8-42dc-80dc-ddd6450d5fbc 61 fields · synced 22 Oct 2026