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One Step HCG Pregnancy Test

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

Ref AD001Model midstream, 1 test/box EMDN W0102160302

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06946679305883 Basic UDI-DIDate17 May 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  • Withdrawn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

Model / Reference
midstream, 1 test/box, AD001
Primary DI / UDI-DI
06946679305883
Basic UDI-DI
B-06946679305883
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class IVD devices for self-testing
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000019359
Authorised representative
MedPath GmbH DE-AR-000000087

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

Properties & raw data

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

Sources (1)

  • EUDAMED 574f1b4e-5de3-4404-8b9f-51db862c18fd 61 fields · synced 24 Oct 2026