Skip to content

TB-IGRA (Lyophilized) Control

by Xiamen Innodx Biotech Co., Ltd. China EUDAMED

Ref TB-IGRA CON EMDN W0102152099

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-TB-IGRA_CONG5 Basic UDI-DIDate30 Jun 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  • Withdrawn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

Model / Reference
TB-IGRA CON
Primary DI / UDI-DI
D-TB-IGRA_CONG5
Basic UDI-DI
B-TB-IGRA_CONG5
EMDN Code
W0102152099 Controls- immunochemistry - other
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000041071
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Xiamen Innodx Biotech Co., Ltd.

See all devices from Xiamen Innodx Biotech Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED D-TB-IGRA_CONG5|B-TB-IGRA_CONG5 61 fields · synced 25 Oct 2026