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GeneStream GBS Assay

by Hangzhou Danwei Biotechnology Co., Ltd China EUDAMED

Ref CGBS01A-AHG4E

EMDN W0105011104

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-697603130CGBS01ACKVM Basic UDI-DIDate20 May 2026RegisteredStatusActive

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

Device Name
GeneStream GBS Assay
Model / Reference
CGBS01A-AHG4E
Primary DI / UDI-DI
D-697603130CGBS01ACKVM
Basic UDI-DI
B-697603130CGBS01ACKVM
EMDN Code
W0105011104 Strep. b detection by na reagents
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000041344
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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See all devices from Hangzhou Danwei Biotechnology 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 91f7211e-8f18-41d9-b374-2010e5fa5b7a 61 fields · synced 22 Oct 2026