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One-Step Pregnancy Test

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

Ref WH-FT-S0x0101; WH-FT-S0x0102; WH-FT-S0x0103; WH-FT-S0x0107Model Strip /Cassette /Dip card /Midstream

Active European Union and United States

CE IVDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K041273↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-6909620WHSHCG8DGP Basic UDI-DI D-6909620WHSHCG8DGPUDI-DIDate9 Mar 2023RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK041273 Date20 May 2004IssuedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/IVDD Active

Specification

EUDAMED · 510(k)

Device Name
Pregnancy Tests
Model / Reference
Strip /Cassette /Dip card /Midstream, WH-FT-S0x0101, WH-FT-S0x0102, WH-FT-S0x0103, WH-FT-S0x0107
Primary DI / UDI-DI
D-6909620WHSHCG8DGP
Basic UDI-DI
B-6909620WHSHCG8DGP
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class IVD devices for self-testing
EU 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.

See all devices from W.H.P.M. Bioresearch & Technology Co., Ltd. →

Properties

  • 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