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Carbapenemase Rapid Test Cassette -KPC/NDM/VIM/IMP/OXA-48

by Tianjin Jianbo Biological Co., Ltd. EUDAMED

Active European Union

Ref C6003

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975344570110 Basic UDI-DIDate7 May 2025RegisteredStatusActive

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  • Withdrawn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
Carbapenemase Rapid Test Cassette-KPC/NDM/VIM/IMP/OXA-48
Model / Reference
C6003
Primary DI / UDI-DI
06975344570110
Basic UDI-DI
B-06975344570110
EMDN Code
W0104080506 Targeted resistance tests - carbapenemase
Device Class
Class IVD General
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000040307
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Tianjin Jianbo Biological Co., Ltd.

Properties

  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No