Skip to content

Rifampicin-resistant Mycobacterium Tuberculosis Kit (Fluorescent PCR)

by Henan Vacure Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref /

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-TD-HNVC-CED-06XC 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  • Withdrawn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

Device Name
Rifampicin-resistant Mycobacterium Tuberculosis Kit (Fluorescent PCR)
Model / Reference
/
Primary DI / UDI-DI
D-TD-HNVC-CED-06XC
Basic UDI-DI
B-TD-HNVC-CED-06XC
EMDN Code
W0105010703 Mycobacterial 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

Show properties
  • 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