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Rapid MTBC DNA Test

by Healgen Life Science, LLC United States EUDAMED

Ref RMTB01-AHG5E, RMTB01-AHG25E EMDN W0105010703

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-81649002RMTB01N5WX Basic UDI-DIDate26 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  • Withdrawn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 25 Oct 2026

Device Name
Rapid MTBC DNA Test
Model / Reference
RMTB01-AHG5E, RMTB01-AHG25E
Primary DI / UDI-DI
D-81649002RMTB01N5WX
Basic UDI-DI
B-81649002RMTB01N5WX
EMDN Code
W0105010703 Mycobacterial detection by na reagents
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000043017
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Healgen Life Science LLC

See all devices from Healgen Life Science LLC →

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 df0543e7-ec4f-47be-bc4e-82bdd9608b80-1 61 fields · synced 25 Oct 2026