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One+Step® Follicle Stimulating Hormone Tests

by W.H.P.M. Bioresearch & Technology Co., Ltd. China EUDAMED

Ref WH-FT-S190307Model Midstream

EMDN W0102160301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-WH-FT-S190307CM Basic UDI-DIDate16 Oct 2026RegisteredStatusActive

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 24 Oct 2026

Device Name
Follicle Stimulating Hormone Tests
Model / Reference
Midstream, WH-FT-S190307
Primary DI / UDI-DI
D-WH-FT-S190307CM
Basic UDI-DI
B-WH-FT-S190307CM
EMDN Code
W0102160301 Fsh - rt & poc
Device Class
Class IVD devices for self-testing
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000003007
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from W.H.P.M. Bioresearch & Technology Co., Ltd.

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Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Self Testing
Other properties (8)
  • Sterile: No
  • 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 D-WH-FT-S190307CM|B-WH-FT-S190307CM 61 fields · synced 24 Oct 2026