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Siron LS (aPTT liquid)

by Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH 2 variants

Ref 5035109Model Siron LS

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-09120036862500 Basic UDI-DI 09120036862500UDI-DIDate17 Jul 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-09120036862500 Basic UDI-DI 09120036862500UDI-DIDate17 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  • Withdrawn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
Siron LS
Device Name
Siron LS (aPTT liquid)
Model / Reference
Siron LS, 5035109
Primary DI / UDI-DI
09120036862500
Basic UDI-DI
B-09120036862500, 912003686TC6S000000193
EMDN Code
W0103020102 Activated partial thromboplastin time
Device Class
Class IVD General
Class C
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