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One Step HCG Pregnancy Test (Colloidal Gold)

by Wuhan J.H. Bio-Tech Co., Ltd. China EUDAMED

Ref IVDD EMDN W0102160304

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06946679306781 Basic UDI-DIDate26 Mar 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
One Step HCG Pregnancy Test (Colloidal Gold)
Model / Reference
IVDD
Primary DI / UDI-DI
06946679306781
Basic UDI-DI
B-06946679306781
EMDN Code
W0102160304 Lh - rt & poc
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000019359
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from Wuhan J.H. Bio-Tech Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Reagent
  • Self Testing
Other properties (7)
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 03f866cf-03e5-4c2a-b9f2-344934f984ab 61 fields · synced 24 Oct 2026