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HC-10 Portable Colloidal Gold Immunoassay Analyzer

by Nanjing Synthgene Medical Technology Co., Ltd. China EUDAMED

Ref HC10

EMDN W0201020280

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697447330HC10HD Basic UDI-DIDate9 Jun 2023RegisteredStatusActive

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
HC10
Primary DI / UDI-DI
06974473303712
Basic UDI-DI
697447330HC10HD
Direct Marketing DI
06974473303712
EMDN Code
W0201020280 Limited panel immunochemistry analysers - hardware accessories
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000023810
Authorised representative
MedPath GmbH DE-AR-000000087

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Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED 973df53f-86f5-4ee9-b621-ebd4a0bc406b 61 fields · synced 22 Oct 2026