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SEED 1dayPure moisture (32)

by SEED Co., Ltd. Japan EUDAMED

Ref manyModel Sterile vision corrective contact lenses

EMDN Q021004010101

Regulatory status

as of 25 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
496124321900S3Z
Basic UDI-DI
4961243SEEDCL01Y3
EMDN Code
Q021004010101 Contact lenses - hydrogel, daily single-use
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 906fdf17-0b36-4d9c-bfea-11ca118e799d 61 fields · synced 22 Oct 2026