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Typhoid IgG/IgM Rapid Test Kit (Colloidal gold method)

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

Ref CR020

EMDN W0105011799

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974473301350 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
CR020
Primary DI / UDI-DI
06974473301350, D-CNMF000054349CR020G9
Basic UDI-DI
B-06974473301350, B-CNMF000054349CR020G9
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.

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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 3ad49741-3ed4-486a-b3a8-fd0362d14ae9 61 fields · synced 22 Oct 2026
  • EUDAMED D-CNMF000054349CR020G9|B-CNMF000054349CR020G9 61 fields · synced 18 Jun 2026