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SD02H-Huv (6)

by SEED Co., Ltd. Japan EUDAMED

Ref manyModel Sterile vision corrective contact lenses

EMDN Q0210040102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberJP26/00000021 Date30 Apr 2026IssuedStatusActive expires 22 Jan 2031

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • JP26/00000021 Amended

    Quality management system EU MDR

    Notified body
    Notified body 1639
    Issued
    30 Apr 2026
    Expires
    22 Jan 2031
    Reason
    Mnf data change

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
Sterile vision corrective contact lenses, many
Primary DI / UDI-DI
496124326770S6D
Basic UDI-DI
4961243SEEDCL01Y3
EMDN Code
Q0210040102 Contact lenses - hydrogel, reusable
Device Class
Class IIa
Special Device Type
Standard soft contact lenses
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
JP-MF-000020702
Authorised representative
Wöhlk Contactlinsen GmbH DE-AR-000040895

Other devices from SEED Co., Ltd.

See all devices from SEED Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • CMR Substance
Other properties (11)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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 456c961d-9c7e-48a8-a6c0-0e4adf58a2a5 61 fields · synced 22 Oct 2026