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Ds-Eia-Thyroid-Anti-Tg

by RPC Diagnostic Systems Ltd. Russia EUDAMED

Ref TH-451/1.1 EMDN W0102100303

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04605979401689 Basic UDI-DIDate10 Oct 2025RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
“ds-Eia-Thyroid-Anti-Tg” Enzyme Immunoassay for the Quantitative Determination of Anti-Thyroglobulin Autoantibodies Concentration
Model / Reference
TH-451/1.1
Primary DI / UDI-DI
04605979401689
Basic UDI-DI
B-04605979401689
EMDN Code
W0102100303 Thyroglobulin autoantibody
Device Class
Class IVD General

Manufacturer details

EUDAMED SRN
RU-MF-000043555
Authorised representative
AB Diagnostic Systems GmbH DE-AR-000025750

Properties & raw data

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

Sources (1)

  • EUDAMED 3721a0fc-1e1a-4069-b836-348f241dc8d4 61 fields · synced 23 Oct 2026