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cleadew SL

by OPHTECS Corporation Japan EUDAMED

Ref 75200, 75210, 75212, 75232

EMDN Q02030204

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number49500551100NY Basic UDI-DIDate6 May 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
75200, 75210, 75212, 75232
Primary DI / UDI-DI
04950055206161, 04950055206178, 04950055206260, 04950055206277
Basic UDI-DI
49500551100NY
EMDN Code
Q02030204 Contact lenses storing and cleaning solutions
Device Class
Class IIb
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
JP-MF-000014564
Authorised representative
OPHTECS Europe B.V. NL-AR-000011893

Other devices from Ophtecs Corporation

See all devices from Ophtecs Corporation →

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 (4)

  • EUDAMED 463b688c-d6fa-4719-9c20-c4bdb9fe82d0 61 fields · synced 22 Oct 2026
  • EUDAMED 04950055206178|49500551100NY 61 fields · synced 17 May 2026
  • EUDAMED 04950055206260|49500551100NY 61 fields · synced 18 May 2026
  • EUDAMED 04950055206277|49500551100NY 61 fields · synced 18 May 2026