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MTB/NTM Assay

by Zhejiang Orient Gene Biotech Co., Ltd China EUDAMED

Ref CMTBNTM01A-AOG4E

EMDN W0105010703

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-CMTBNTM01A-AOGS2 Basic UDI-DIDate11 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
MTB/NTM Assay
Model / Reference
CMTBNTM01A-AOG4E
Primary DI / UDI-DI
D-CMTBNTM01A-AOGS2
Basic UDI-DI
B-CMTBNTM01A-AOGS2
EMDN Code
W0105010703 Mycobacterial detection by na reagents
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000017965
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Zhejiang Orient Gene Biotech Co., Ltd.

See all devices from Zhejiang Orient Gene Biotech Co., Ltd. →

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 D-CMTBNTM01A-AOGS2|B-CMTBNTM01A-AOGS2 61 fields · synced 25 Oct 2026