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Factor IX native Deficient Plasma

by Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH Austria EUDAMED

Ref 5164008Model Factor IX native Deficient Plasma

EMDN W0103020208

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-09120036860445 Basic UDI-DIDate16 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Factor IX native Deficient Plasma
Model / Reference
Factor IX native Deficient Plasma, 5164008
Primary DI / UDI-DI
09120036860445
Basic UDI-DI
B-09120036860445
EMDN Code
W0103020208 Coagulation factor ix
Device Class
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 (7)
  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 09120036860445|B-09120036860445 61 fields · synced 24 Oct 2026