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HemoPOC Coagulometer

by Helixgen (GUANGZHOU) Co., Ltd. China EUDAMED

Ref HZ-200401Model HGINR-1

EMDN W02020602

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06953792720141 Basic UDI-DIDate27 Mar 2025RegisteredStatusActive

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
HemoPOC Coagulometer
Model / Reference
HGINR-1, HZ-200401
Primary DI / UDI-DI
06953792720141
Basic UDI-DI
B-06953792720141
EMDN Code
W02020602 Rapid test hemostasis instruments
Device Class
Class IVD devices for self-testing
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000034593
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Helixgen (GUANGZHOU) Co., Ltd.

Properties & raw data

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

Sources (1)

  • EUDAMED 5d3b4451-2ffa-466a-a02b-d47a2210f7a5 61 fields · synced 22 Oct 2026