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Protein Induced by Vitamin K Absence or Antagonist-II Assay kit(Chemiluminescence Immunoassay Method）

by Shenzhen Dake Medical Technology Co., Ltd China EUDAMED

Ref 2×50 testModel 25 tests，50 tests，2×50 tests，100 tests，2×100 tests

EMDN W0102039017

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697846523TumorC029X Basic UDI-DIDate26 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
25 tests，50 tests，2×50 tests，100 tests，2×100 tests, 2×50 test
Primary DI / UDI-DI
06978465236477
Basic UDI-DI
697846523TumorC029X
EMDN Code
W0102039017 Protein induced by vitamin k absence or antagonist-ii (pivka-ii)
Device Class
Class C
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000047336
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Properties & raw data

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

Sources (1)

  • EUDAMED 021cd202-2fcd-4498-a35b-9cd3108fe918 61 fields · synced 22 Oct 2026