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Hokapi™ Psa

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

Ref 010103101

EMDN W0102030113

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69713904301037D Basic UDI-DIDate2 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
010103101
Primary DI / UDI-DI
06971390434987
Basic UDI-DI
69713904301037D
Direct Marketing DI
06971390434987
EMDN Code
W0102030113 Total prostatic specific 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 6308bfe6-c9ec-4b86-8eb3-eb8fcfd0b7b5 61 fields · synced 23 Oct 2026