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IMMULITE D-Dimer Control Module

by Siemens Healthcare Diagnostics Products Ltd. EUDAMED

Active European Union

Ref 10385330Model IVDR_67_LLB_DUB-C_C_REAG_D-Dimer Control Module

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0405686901476VX Basic UDI-DIDate29 May 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  • Withdrawn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_67_LLB_DUB-C_C_REAG_D-Dimer Control Module
Model / Reference
IVDR_67_LLB_DUB-C_C_REAG_D-Dimer Control Module, 10385330
Primary DI / UDI-DI
00630414953168
Basic UDI-DI
0405686901476VX
EMDN Code
W0102152099 Controls- immunochemistry - other
Device Class
Class C
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
GB-MF-000016339
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited IE-AR-000006763

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Properties

  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

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