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IMMULITE 2000 Syphilis Screen

by Siemens Healthcare Diagnostics Products Ltd. United States EUDAMED

Ref 10488319Model IVDR_67_LLB_DUB-C_C_KIT_Syphilis Screen

EMDN W0105010301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0405686900730VF Basic UDI-DIDate1 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
IVDR_67_LLB_DUB-C_C_KIT_Syphilis Screen
Model / Reference
IVDR_67_LLB_DUB-C_C_KIT_Syphilis Screen, 10488319
Primary DI / UDI-DI
00630414999807
Basic UDI-DI
0405686900730VF
EMDN Code
W0105010301 Syphilis antigen detection
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

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 00630414999807|0405686900730VF 61 fields · synced 22 Oct 2026