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GeneStream MTB MDR Assay

by Hangzhou Danwei Biotechnology Co., Ltd EUDAMED

Active European Union

Ref CMTBMDR01A-AHG4E

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-697603130CMTBMDR01A3QKW Basic UDI-DIDate20 May 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
GeneStream MTB MDR Assay
Model / Reference
CMTBMDR01A-AHG4E
Primary DI / UDI-DI
D-697603130CMTBMDR01A3QKW
Basic UDI-DI
B-697603130CMTBMDR01A3QKW
EMDN Code
W0105040511 Dengue virus - 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

Other devices from Hangzhou Danwei Biotechnology Co., Ltd

See all devices from Hangzhou Danwei Biotechnology Co., Ltd →

Properties

  • 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