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INNODX TRAb CMIA

by Xiamen Innodx Biotech Co., Ltd. China EUDAMED

Ref KR-TRAb-01100 EMDN W0102100302

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-KR-TRAb-01100XE Basic UDI-DIDate21 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  • Withdrawn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 24 Oct 2026

Model / Reference
KR-TRAb-01100
Primary DI / UDI-DI
D-KR-TRAb-01100XE
Basic UDI-DI
B-KR-TRAb-01100XE
EMDN Code
W0102100302 Tsh receptor antibodies
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
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED D-KR-TRAB-01100XE|B-KR-TRAB-01100XE 61 fields · synced 24 Oct 2026