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cleadew

by OPHTECS Corporation Japan EUDAMED

Ref 75052, 75220, 75221

EMDN Q02030204

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number49500551040P7 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

Trade Name
cleadew
cleadew SLi
Model / Reference
75052, 75220, 75221
Primary DI / UDI-DI
04950055604318, 04950055206185, 04950055206253
Basic UDI-DI
49500551040P7, 49500551110P3
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 YesEUDAMEDNoEUDAMED
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 (3)

  • EUDAMED e918cd22-90c3-4890-baee-c8b62e63dfc5 61 fields · synced 22 Oct 2026
  • EUDAMED 04950055206185|49500551110P3 61 fields · synced 18 May 2026
  • EUDAMED 04950055206253|49500551110P3 61 fields · synced 18 May 2026