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INNOVANCE D-Dimer Controls

by Siemens Healthcare Diagnostics Products GmbH EUDAMED

Active European Union

Ref 10446005Model IVDR_27_MAR EB_C_PROF_REAG_INN_D-Di_Con

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0405686900175V7 Basic UDI-DIDate15 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

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.

Specification

EUDAMED

Device Name
IVDR_27_MAR EB_C_PROF_REAG_INN_D-Di_Con
Model / Reference
IVDR_27_MAR EB_C_PROF_REAG_INN_D-Di_Con, 10446005
Primary DI / UDI-DI
00842768007019
Basic UDI-DI
0405686900175V7
Unit of Use DI
00630414304717
EMDN Code
W0103020799 Haemostasis controls - other
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

  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No