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Preview™ Pregnancy Test

by Guangzhou Wondfo Biotech Co., Ltd. China EUDAMED

Ref W001P0728

EMDN W0102160302

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69332898CE1206EV Basic UDI-DIDate29 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED · synced 24 Oct 2026

Device Name
One Step Pregnancy Test
Model / Reference
W001P0728
Primary DI / UDI-DI
06933289813600
Basic UDI-DI
69332898CE1206EV
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class B
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
CN-MF-000000689
Authorised representative
QbD RepS BV BE-AR-000000040

Other devices from Guangzhou Wondfo Biotech Co., Ltd.

See all devices from Guangzhou Wondfo Biotech Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Self Testing
  • Near-Patient Testing
  • Professional Testing
Other properties (5)
  • Sterile: No
  • Human Tissues: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 06933289813600|69332898CE1206EV 61 fields · synced 24 Oct 2026