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Digital HCG Pregnancy Test

by Core Technology Co., Ltd. EUDAMED

Active European Union

Ref AD10-31Model Midstream

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06942468190050 Basic UDI-DIDate15 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

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.

Specification

EUDAMED

Model / Reference
Midstream, AD10-31
Primary DI / UDI-DI
06942468190050
Basic UDI-DI
B-06942468190050
EMDN Code
W0102160399 Fertility/pregnancy rt & poc - other
Device Class
Class IVD devices for self-testing
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
CN-MF-000023522
Authorised representative
Wellkang Ltd XI-AR-000001836

Other devices from Core Technology Co., Ltd.

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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