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Strep B Antigen Rapid Test Kit (Colloidal gold method)

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

Ref CR029, CR057 EMDN W0105090103

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974473307871 Basic UDI-DIDate29 Aug 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
CR029, CR057
Primary DI / UDI-DI
06974473307871, D-CNMF000054349CR057b64
Basic UDI-DI
B-06974473307871, B-CNMF000054349CR057b64
EMDN Code
W0105090103, W0105090104
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 a048e63e-130b-4766-a081-6106f002ea0b 61 fields · synced 22 Oct 2026
  • EUDAMED D-CNMF000054349CR057B64|B-CNMF000054349CR057B64 61 fields · synced 9 Jul 2026