Skip to content

Dade Actin FSL Activated PTT Reagent

by Siemens Healthcare Diagnostics Products GmbH FDA registration: Germany EUDAMED

Ref 10284499Model IVDR_27_MAR EB_C_PROF_REAG_Actin_FSL EMDN W0103020102

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0405686900166V6 Basic UDI-DIDate12 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
IVDR_27_MAR EB_C_PROF_REAG_Actin_FSL
Model / Reference
IVDR_27_MAR EB_C_PROF_REAG_Actin_FSL, 10284499
Primary DI / UDI-DI
00842768030833
Basic UDI-DI
0405686900166V6
Unit of Use DI
00630414304649
EMDN Code
W0103020102 Activated partial thromboplastin time
Device Class
Class C
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000005039

Other devices from Siemens Healthcare Diagnostics Products GmbH

See all devices from Siemens Healthcare Diagnostics Products GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 00842768030833|0405686900166V6 61 fields · synced 24 Oct 2026