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Alpha-Fetoprotein (AFP) Reagent Kit (Chemiluminescent Immunoassay)

by Rayto Life and Analytical Sciences Co., Ltd. China EUDAMED

Ref R15915Model 30 Tests/Kit

EMDN W0102030399

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-R159153F Basic UDI-DIDate10 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

Ireland
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

EU market availability

Available in 1 country, as listed in EUDAMED:

  • Ireland

Last checked 24 Oct 2026.

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Alpha-Fetoprotein (AFP) Reagent Kit (Chemiluminescent Immunoassay)
Model / Reference
30 Tests/Kit, R15915
Primary DI / UDI-DI
D-R159153F
Basic UDI-DI
B-R159153F
EMDN Code
W0102030399 Other oncoproteins
Device Class
Class IVD General
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000011141
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Rayto Life and Analytical Sciences Co., Ltd.

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Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED D-R159153F|B-R159153F 61 fields · synced 24 Oct 2026