Skip to content

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

by Zhuhai Encode Medical Engineering Co., Ltd. EUDAMED

Active European Union

Ref PMTB0548Model MTB and Drug Resistance Gene Mutation Detection Kit 48tests/kit

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974566304046 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  • Withdrawn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

Model / Reference
MTB and Drug Resistance Gene Mutation Detection Kit 48tests/kit, PMTB0548
Primary DI / UDI-DI
06974566304046
Market of Registration
Bulgaria

Manufacturer details

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

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

See all devices from Zhuhai Encode Medical Engineering Co., Ltd. →

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 dbf16cbc-bfe0-4e26-a233-aa4841b17d1c 61 fields · synced 25 Oct 2026