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CelQuant 3i Rinse

by Meril Diagnostics Pvt. Ltd. India EUDAMED

Ref CLZCCR-04

EMDN W0103010105

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8905459RINSEHMG6 Basic UDI-DIDate20 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
CelQuant 3i Rinse
Model / Reference
CLZCCR-04
Primary DI / UDI-DI
18906074560756
Basic UDI-DI
8905459RINSEHMG6
Direct Marketing DI
18906074560756
EMDN Code
W0103010105 Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)
Device Class
Class A
Market of Registration
Bulgaria

Manufacturer details

EUDAMED SRN
IN-MF-000028158
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Meril Diagnostics Pvt. Ltd.

See all devices from Meril Diagnostics Pvt. Ltd. →

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 265a23db-fab1-40e5-b29e-1f6124b54ce3 61 fields · synced 22 Oct 2026