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Hokapi™ Scc

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

Ref 010113601

EMDN W0102030116

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69713904301137G Basic UDI-DIDate9 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
010113601
Primary DI / UDI-DI
06939716404625
Basic UDI-DI
69713904301137G
Direct Marketing DI
06939716404625
EMDN Code
W0102030116 Squamous cell carcinoma antigen
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
  • 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

Sources (1)

  • EUDAMED e6049a07-4aa1-4b00-ac09-556c639c2ca6 61 fields · synced 24 Oct 2026