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Passive Particle Agglutination Test for Detection of Antibodies to Treponema Pallidum

by Zhuhai Livzon Diagnostics Inc. EUDAMED

Active European Union

Ref A00201220Model 100 tests/kit (20×5)；220 tests/kit (55 × 4)

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6935771608411BB Basic UDI-DIDate26 May 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  • Withdrawn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

Device Name
Passive Particle Agglutination Test for Detection of Antibodies to Treponema Pallidum
Model / Reference
100 tests/kit (20×5)；220 tests/kit (55 × 4), A00201220
Primary DI / UDI-DI
06935771608428
Basic UDI-DI
6935771608411BB
EMDN Code
W0105010302 Syphilis antibody assays total
Device Class
Class C
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
CN-MF-000053720
Authorised representative
QbD RepS BV BE-AR-000000040

Other devices from Zhuhai Livzon Diagnostics Inc.

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