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i-Track 10 Cartridge Check System

by Immunodiagnostic Systems SA EUDAMED

Active European Union

Ref TD IS-6010Model IS-6010

Regulatory status

as of 26 Oct 2026

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

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  • Withdrawn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

Device Name
IDS-iSYS Cartridge Checking System (CCS)
Model / Reference
IS-6010, TD IS-6010
Primary DI / UDI-DI
05425030420034
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

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Properties

Show properties
  • 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