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Typhoid Antigen Rapid Test Kit (Colloidal gold method)

by Nanjing Synthgene Medical Technology Co., Ltd. China EUDAMED

Ref CR021

EMDN W0105011799

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974473303132 Basic UDI-DIDate5 Sep 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
CR021
Primary DI / UDI-DI
06974473303132, D-CNMF000054349CR021GB
Basic UDI-DI
B-06974473303132, B-CNMF000054349CR021GB
EMDN Code
W0105011799, W0105090199
Device Class
Class IVD General
Market of Registration
Netherlands
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000023810
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Nanjing Synthgene Medical Technology Co., Ltd.

See all devices from Nanjing Synthgene Medical Technology Co., Ltd. →

Properties & raw data

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

Sources (2)

  • EUDAMED b02e4657-c5f5-4856-b1de-cf54908190ee 61 fields · synced 22 Oct 2026
  • EUDAMED D-CNMF000054349CR021GB|B-CNMF000054349CR021GB 61 fields · synced 22 Jul 2026