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Factor IX immunads. Deficient Plasma

by Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH

Ref 5164004Model Factor IX immunads. Deficient Plasma, Factor IX DP

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/IVDR NumberB-09120036862685 Basic UDI-DI 09120036862685UDI-DIDate16 Jul 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-09120036862685 Basic UDI-DI 09120036862685UDI-DIDate16 Jul 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  • Withdrawn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/IVDR, CE/IVDD Active

Specification

EUDAMED

Trade Name
Factor IX DP
Device Name
Factor IX immunads. Deficient Plasma
Model / Reference
Factor IX immunads. Deficient Plasma, 5164004, Factor IX DP
Primary DI / UDI-DI
09120036862685
Basic UDI-DI
B-09120036862685, 912003686TC490000001QP
EMDN Code
W0103020208 Coagulation factor IX
Device Class
Class IVD General
Class C
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
AT-MF-000024115

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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