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Group B Streptococcus Nucleic Acid Detection Kit (Fluorescent PCR)

by Triplex International Biosciences (China) Co., LTD. China EUDAMED

Ref C011936 EMDN W0105011104

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06950917910555 Basic UDI-DIDate23 Oct 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  • Withdrawn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

Device Name
Group B Streptococcus Nucleic Acid Detection Kit (Fluorescent PCR)
Model / Reference
C011936
Primary DI / UDI-DI
06950917910555
Basic UDI-DI
B-06950917910555
EMDN Code
W0105011104 Strep. b detection by na reagents
Device Class
Class IVD General
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000001097
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Triplex International Biosciences (China) Co., LTD.

See all devices from Triplex International Biosciences (China) Co., LTD. →

Properties & raw data

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

Sources (1)

  • EUDAMED 98d7715d-0fa0-45ca-855d-568983b86c83 61 fields · synced 22 Oct 2026