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Factor IX DP native

by Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH Austria EUDAMED

Ref 5164016Model Factor IX DP

EMDN W0103020208

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number912003686TC490000001QP 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
Factor IX DP
Model / Reference
Factor IX DP, 5164016
Primary DI / UDI-DI
09120036860452
Basic UDI-DI
912003686TC490000001QP
EMDN Code
W0103020208 Coagulation factor ix
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
  • 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 (1)

  • EUDAMED d696546e-9c91-49b6-afb3-14b1e2d0f6dc 61 fields · synced 24 Oct 2026