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Cartridge Checking System

by Immunodiagnostic Systems SA Belgium EUDAMED

Ref 41401Model IS-6010

EMDN W0102152099

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5425030426012S5 Basic UDI-DIDate10 Jun 2022RegisteredStatusActive

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
IDS-iSYS Cartridge Checking System (CCS)
Model / Reference
IS-6010, 41401
Primary DI / UDI-DI
05425030420072
Basic UDI-DI
5425030426012S5
EMDN Code
W0102152099 Controls- immunochemistry - other
Device Class
Class A
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000015341

Other devices from Immunodiagnostic Systems SA

See all devices from Immunodiagnostic Systems SA →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED efbcecd3-ebc9-4499-8105-8d6e73db3f47 61 fields · synced 22 Oct 2026