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MTB Drug Resistance Gene Mutation Detection Kit (Fluorescence PCR Melting Curve Analysis)

by Zhuhai Encode Medical Engineering Co., Ltd. China EUDAMED

Ref PMTB0348Model MTB and RFP/INH Drug Resistance Gene Mutation Detection Kit 48tests/kit EMDN W0105010703

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974566304015 Basic UDI-DIDate12 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  • Withdrawn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 · synced 24 Oct 2026

Model / Reference
MTB and RFP/INH Drug Resistance Gene Mutation Detection Kit 48tests/kit, PMTB0348
Primary DI / UDI-DI
06974566304015
Basic UDI-DI
B-06974566304015
EMDN Code
W0105010703 Mycobacterial detection by na reagents
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000019361
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Zhuhai Encode Medical Engineering Co., Ltd.

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Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED fcf6cfeb-a185-46f0-8e72-6490c01168ff 61 fields · synced 24 Oct 2026