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Siron LIS

by Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH

Ref 5035118Model Siron LIS

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 Number912003686TC6L00000014W Basic UDI-DI 09120036863415UDI-DIDate11 Aug 2026RegisteredStatusActive
European UnionCE/IVDR Number912003686TC6L00000014W Basic UDI-DI 09120036863415UDI-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  • Withdrawn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
Siron LIS (aPTT liquid)
Model / Reference
Siron LIS, 5035118
Primary DI / UDI-DI
09120036863415
Basic UDI-DI
912003686TC6L00000014W, B-09120036863415
EMDN Code
W0103020102 Activated partial thromboplastin time
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