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Factor IX DP

by Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH

Ref 5164003Model Factor IX DP, Factor IX immunads. Deficient Plasma

Active European Union

CE IVDR CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number912003686TC490000001QP Basic UDI-DI 09120036860438UDI-DIDate11 Aug 2026RegisteredStatusActive
European UnionCE/IVDR Number912003686TC490000001QP Basic UDI-DI 09120036860438UDI-DIDate11 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD, CE/IVDR Active

Specification

EUDAMED

Device Name
Factor IX immunads. Deficient Plasma
Model / Reference
Factor IX DP, 5164003, Factor IX immunads. Deficient Plasma
Primary DI / UDI-DI
09120036860438
Basic UDI-DI
912003686TC490000001QP, B-09120036860438
EMDN Code
W0103020208 Coagulation factor IX
Device Class
Class C
Class IVD General
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
AT-MF-000024115

Other devices from Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH

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Properties

  • 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