Skip to content

ALPHA-FetoProtein (AFP) Detection Kit (Magnetic Particle CLIA)

by Tianjin Bioscience Diagnostic Technology Co., Ltd. China EUDAMED

Ref H201.02.021C2.610 Model 100 TEST/KIT （CALIBRATION 6×1）

EMDN W0102039001

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06973914383146 Basic UDI-DIDate3 Aug 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
ALPHA-FetoProtein (AFP) Detection Kit (Magnetic Particle CLIA)
Model / Reference
100 TEST/KIT （CALIBRATION 6×1）, H201.02.021C2.610
Primary DI / UDI-DI
06973914383146
Basic UDI-DI
B-06973914383146
EMDN Code
W0102039001 Alphafetoprotein
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000023301
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Tianjin Bioscience Diagnostic Technology Co., Ltd.

See all devices from Tianjin Bioscience Diagnostic Technology Co., Ltd. →

Properties & raw data

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

Sources (1)

  • EUDAMED da62e998-c534-445e-b203-ed8a6f2ac8eb 61 fields · synced 22 Oct 2026