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Factor VIII INH Kit

by Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH

Ref 5152009Model Factor VIII INH Kit

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number912003686TC0F0000001UX Basic UDI-DI 09120036862333UDI-DIDate10 Aug 2026RegisteredStatusActive
European UnionCE/IVDR Number912003686TC0F0000001UX Basic UDI-DI 09120036862333UDI-DIDate10 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  • Withdrawn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 VIII Inhibitor Reagent Kit HCV neg.
Model / Reference
Factor VIII INH Kit, 5152009
Primary DI / UDI-DI
09120036862333
Basic UDI-DI
912003686TC0F0000001UX, B-09120036862333
EMDN Code
W0103020603 Coagulation factor VIII inhibitor
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