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HISCL HIT IgG Control

by Sysmex Corporation Japan EUDAMED

Ref CL306546

EMDN W0103020615

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number4987562HITIgGCont9L Basic UDI-DIDate13 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
CL306546
Primary DI / UDI-DI
04987562506361
Basic UDI-DI
4987562HITIgGCont9L
EMDN Code
W0103020615 Coagulation inhibitors/thrombophilia markers for heparin induced thrombocytopenia test (hit)
Device Class
Class C
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
JP-MF-000014037
Authorised representative
Sysmex Europe SE DE-AR-000022333

Other devices from Sysmex Corporation

See all devices from Sysmex Corporation →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 04987562506361|4987562HITIGGCONT9L 61 fields · synced 25 Oct 2026