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AFP Assay Kit (ECLIA)

by Jiangsu Sunlant Bioengineering Co., Ltd. China EUDAMED

Ref SE-K001

EMDN W0102039001

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-SEK001D8 Basic UDI-DIDate14 Feb 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 24 Oct 2026

Model / Reference
SE-K001
Primary DI / UDI-DI
D-SEK001D8
Basic UDI-DI
B-SEK001D8
EMDN Code
W0102039001 Alphafetoprotein
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000025940
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Jiangsu Sunlant Bioengineering Co., Ltd.

See all devices from Jiangsu Sunlant Bioengineering Co., Ltd. →

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 7d757f6d-9204-43f5-9447-fb2841f955ff 61 fields · synced 24 Oct 2026