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Hokapi™ Pivka-Ii

by Suzhou Hokapi Biomedical Engineering Co., Ltd.. China EUDAMED

Ref 010125001

EMDN W0102039017

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number693971640125LC Basic UDI-DIDate10 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
010125001
Primary DI / UDI-DI
06939716405387
Basic UDI-DI
693971640125LC
Direct Marketing DI
06939716405387
EMDN Code
W0102039017 Protein induced by vitamin k absence or antagonist-ii (pivka-ii)
Device Class
Class C
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000013723
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Suzhou Hokapi Biomedical Engineering Co., Ltd..

See all devices from Suzhou Hokapi Biomedical Engineering Co., Ltd.. →

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 db0635f2-a5e2-4b3c-9d86-7d280540c5dd 61 fields · synced 24 Oct 2026