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Cleanac-3 MEK 620H

by Nihon Kohden India Private Limited India EUDAMED

Ref MEK-620H EMDN W0103010105

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8908022609IVD0029S Basic UDI-DIDate20 Jul 2025RegisteredStatusActive

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  • Withdrawn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 24 Oct 2026

Device Name
Detergent
Model / Reference
MEK-620H
Primary DI / UDI-DI
08908022609077
Basic UDI-DI
8908022609IVD0029S
Direct Marketing DI
08908022609077
EMDN Code
W0103010105 Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
IN-MF-000045419
Authorised representative
NIHON KOHDEN EUROPE GmbH DE-AR-000010740

Other devices from Nihon Kohden India Private Limited

See all devices from Nihon Kohden India Private Limited →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED abb16ec8-9b69-416c-948e-2fc090eb3fdd 61 fields · synced 24 Oct 2026