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Abnormal Human Control Plasma

by Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH Austria EUDAMED

Ref 5021021Model Abnormal Control Plasma

EMDN W0103020702

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number912003686TC3P000000155 Basic UDI-DIDate11 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Abnormal Control Plasma
Model / Reference
Abnormal Control Plasma, 5021021
Primary DI / UDI-DI
09120036863446
Basic UDI-DI
912003686TC3P000000155
EMDN Code
W0103020702 Control plasma for haemostasis
Device Class
Class C
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
  • 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 d9dc7693-9a41-476b-a45b-4a8c460190a1 61 fields · synced 24 Oct 2026