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AK-Verification

by Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH Austria EUDAMED

Ref 5010024Model Coumadin Plasma

EMDN W0103020702

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number912003686TC2B0000001TZ Basic UDI-DIDate11 Aug 2026RegisteredStatusActive
European UnionCE/IVDR Number912003686TC2B0000001TZ Basic UDI-DIDate11 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDD, CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Coumadin Plasma
AK-Verification Kit
Model / Reference
Coumadin Plasma, 5010024
Primary DI / UDI-DI
09120036863651
Basic UDI-DI
912003686TC2B0000001TZ, B-09120036863651
EMDN Code
W0103020702 Control plasma for haemostasis
Device Class
Class C
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
AT-MF-000024115

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Properties & raw data

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

Sources (2)

  • EUDAMED 09120036863651|912003686TC2B0000001TZ 61 fields · synced 24 Oct 2026
  • EUDAMED 09120036863651|B-09120036863651 61 fields · synced 24 Oct 2026