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Innodx Tb-Igra Cmia

by Xiamen Innodx Biotech Co., Ltd. EUDAMED

Active European Union

Ref KR-TB-IGRA-01020C

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697360079019K4 Basic UDI-DIDate5 May 2026RegisteredStatusActive
European UnionCE/IVDD Number697360079019K4 Basic UDI-DIDate5 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR, CE/IVDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
KR-TB-IGRA-01020C
Primary DI / UDI-DI
06973600799824, D-KR-TB-IGRA-01020C65
Basic UDI-DI
697360079019K4, B-KR-TB-IGRA-01020C65
EMDN Code
W0105010704 Tb-igra (interferon-gamma-release assay)
Device Class
Class C
Class IVD General
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
CN-MF-000041071
Authorised representative
QbD RepS BV BE-AR-000000040

Other devices from Xiamen Innodx Biotech Co., Ltd.

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Properties

Show properties
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No