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Mycobacterium Tuberculosis Complex Detection Kit (Fluorescence PCR)

by Healgen Scientific Limited Liability Company United States EUDAMED

Ref AMTBC01-AHG48E; AMTBC01-AHG96E; AMTBC01D-AHG48E; AMTBC01D-AHG96E EMDN W0105010703

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-81649002AMTBC01HNZE Basic UDI-DIDate25 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  • Withdrawn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 22 Oct 2026

Device Name
Mycobacterium Tuberculosis Complex Detection Kit (Fluorescence PCR)
Model / Reference
AMTBC01-AHG48E, AMTBC01-AHG96E, AMTBC01D-AHG48E, AMTBC01D-AHG96E
Primary DI / UDI-DI
D-81649002AMTBC01HNZE
Basic UDI-DI
B-81649002AMTBC01HNZE
EMDN Code
W0105010703 Mycobacterial detection by na reagents
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000018839
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Healgen Scientific Limited Liability Company

See all devices from Healgen Scientific Limited Liability Company →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED e7cd360f-c428-4280-9457-c7e5c919ecc8-1 61 fields · synced 22 Oct 2026