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Alpha-fetoprotein （AFP）Assay Kit (Chemiluminescent Microparticle Immunoassay)

by URIT Medical Electronic Co., Ltd. China EUDAMED

Ref USIA00000168M

EMDN W0102039001

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69357407IIAS000016F7 Basic UDI-DIDate17 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Alpha-fetoprotein （AFP）Assay Kit (Chemiluminescent Microparticle Immunoassay)
Model / Reference
USIA00000168M
Primary DI / UDI-DI
06935740732789
Basic UDI-DI
69357407IIAS000016F7
EMDN Code
W0102039001 Alphafetoprotein
Device Class
Class C
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000011840
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from URIT Medical Electronic Co., Ltd.

See all devices from URIT Medical Electronic Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED b0e2567e-2628-4453-a450-490cc48e30db 61 fields · synced 22 Oct 2026