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Technoclot PT Owren automated

by Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH 2 variants

Ref 5005044Model Technoclot PT Owren automated, TECHNOCLOT® PT Owren automated

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 Number912003686TC6A0000001WA Basic UDI-DI 09120036863606UDI-DIDate11 Aug 2026RegisteredStatusActive
European UnionCE/IVDR Number912003686TC6A0000001WA Basic UDI-DI 09120036863606UDI-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  • Withdrawn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
TECHNOCLOT® PT Owren automated
Model / Reference
Technoclot PT Owren automated, 5005044, TECHNOCLOT® PT Owren automated
Primary DI / UDI-DI
09120036863606
Basic UDI-DI
912003686TC6A0000001WA, B-09120036863606
EMDN Code
W0103020199 General coagulation tests - other
Device Class
Class C
Class IVD General
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
AT-MF-000024115

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No