Skip to content

Beta-haemolytic Group B Streptococcus Nucleic Acid Kit (Fluorescent PCR)

by Henan Vacure Biotechnology Co., Ltd. China EUDAMED

Ref / EMDN W0105011104

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-TD-HNVC-CED-04X8 Basic UDI-DIDate25 May 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  • Withdrawn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
Beta-haemolytic Group B Streptococcus Nucleic Acid Kit (Fluorescent PCR)
Model / Reference
/
Primary DI / UDI-DI
D-TD-HNVC-CED-04X8
Basic UDI-DI
B-TD-HNVC-CED-04X8
EMDN Code
W0105011104 Strep. b detection by na reagents
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000023292
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Henan Vacure Biotechnology Co., Ltd.

See all devices from Henan Vacure Biotechnology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 29769593-5d2e-4a55-ac79-b553323b69b7 61 fields · synced 22 Oct 2026