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Anti-TP Chemiluminescent Immunoassay Kit

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref IM4408008

EMDN W0102100301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-IM4408008JQ Basic UDI-DIDate22 May 2022RegisteredStatusActive

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 22 Oct 2026

Device Name
Anti-TP Chemiluminescent Immunoassay Kit
Model / Reference
IM4408008
Primary DI / UDI-DI
D-IM4408008JQ
Basic UDI-DI
B-IM4408008JQ
EMDN Code
W0102100301 Thyroid peroxidase (incl. microsomal) antibodies
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000014618
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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 81bd6ed3-86d3-4102-ab88-b98613f4f69e 61 fields · synced 22 Oct 2026