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cleadew CareSolution

by OPHTECS Corporation Japan EUDAMED

Ref 75310

EMDN Q02030204

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number49500551130P9 Basic UDI-DIDate13 Aug 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
75310
Primary DI / UDI-DI
04950055203436
Basic UDI-DI
49500551130P9
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 (1)

  • EUDAMED c8857110-4691-43d5-82d0-c90a3d1700f5 61 fields · synced 24 Oct 2026