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Alpha-fetoprotein Detection Kit (Chemiluminescence Immunoassay)

by Dirui Industrial Co., Ltd EUDAMED

Active European Union

Ref 3008828Model 14 packaging specifications

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69257945W0102039001R0PV Basic UDI-DIDate28 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
14 packaging specifications, 3008828
Primary DI / UDI-DI
06925794588524
Basic UDI-DI
69257945W0102039001R0PV
EMDN Code
W0102039001 Alphafetoprotein
Device Class
Class C
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000001891
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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Properties

Show properties
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No