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ISOTONAC･3 Mek-640

by Nihon Kohden Corporation Japan EUDAMED

Ref MEK-640-TO EMDN W0103010105

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number4931921IVD0016NY Basic UDI-DIDate22 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Cbc-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-Fluids)
Model / Reference
MEK-640-TO
Primary DI / UDI-DI
04931921054383
Basic UDI-DI
4931921IVD0016NY
EMDN Code
W0103010105 Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
JP-MF-000019022
Authorised representative
NIHON KOHDEN EUROPE GmbH DE-AR-000010740

Other devices from Nihon Kohden Corporation

See all devices from Nihon Kohden Corporation →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 04931921054383|4931921IVD0016NY 61 fields · synced 25 Oct 2026