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Treponema Pallidum Antibody Rapid Test

by Zhejiang Anji Saianfu Biotechnology Co., Ltd. EUDAMED

Withdrawn No longer placed on the EU market

Ref 3021206

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-69743840303636 Basic UDI-DIDate12 Jan 2026RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
3021206
Primary DI / UDI-DI
69743840303636
Basic UDI-DI
B-69743840303636
EMDN Code
W0105090105 Syphilis - rt & poc
Device Class
Class IVD General

Manufacturer details

EUDAMED SRN
CN-MF-000045029
Authorised representative
Lotus NL B.V. NL-AR-000000121

Properties

Show properties
  • Animal Tissues
  • Near-Patient Testing
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No