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PIVKA-II Chemiluminescent Immunoassay Kit

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref IM4402129, IM4493129, IM4406129

EMDN W0102030199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-IM4402129HT Basic UDI-DIDate23 May 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
PIVKA-II Chemiluminescent Immunoassay Kit
Model / Reference
IM4402129, IM4493129, IM4406129
Primary DI / UDI-DI
D-IM4402129HT, D-IM4493129M5, D-IM4406129JP
Basic UDI-DI
B-IM4402129HT, B-IM4493129M5, B-IM4406129JP
EMDN Code
W0102030199 Cancer antigens - other
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000014618
Authorised representative
Humiss International B.V. NL-AR-000001490

Other devices from Maccura Biotechnology Co., Ltd.

See all devices from Maccura Biotechnology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (3)

  • EUDAMED 2a99cf54-e7a8-4254-b7a6-7964f6d3d64e 61 fields · synced 22 Oct 2026
  • EUDAMED 01589aa5-af6b-4207-ba5d-ed42eb64b7d7 61 fields · synced 18 May 2026
  • EUDAMED b10fde25-fdc4-4a27-8d31-91610d3ff96a 61 fields · synced 18 May 2026