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Alpha-Fetoprotein (AFP) Test Kit (Immunofluorescence)

by Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd. China EUDAMED

Ref 2226

EMDN W0102039001

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06978198482264 Basic UDI-DIDate10 Apr 2026RegisteredStatusActive

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

Model / Reference
2226
Primary DI / UDI-DI
06978198482264
Basic UDI-DI
B-06978198482264
EMDN Code
W0102039001 Alphafetoprotein
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000046524
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.

See all devices from Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Near-Patient Testing
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 9414c700-fd17-4f0e-aa55-10c086c17700 61 fields · synced 22 Oct 2026