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One Step Ovulation Test (Colloidal Gold)

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

Ref BD007Model Midstream, 5 tests/box

EMDN W0102160304

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06946679305906 Basic UDI-DIDate21 May 2024RegisteredStatusActive

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

Model / Reference
Midstream, 5 tests/box, BD007
Primary DI / UDI-DI
06946679305906
Basic UDI-DI
B-06946679305906
EMDN Code
W0102160304 Lh - 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 20c66d6d-b13f-405b-a832-822cc46acb5c 61 fields · synced 22 Oct 2026