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Pregnancy HCG test

by Shenzhen GLD Biotechnology Ltd. China EUDAMED

Ref 17484 EMDN W0102050205

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05711383000109 Basic UDI-DIDate5 Jun 2023RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Urine pregnancy Rapid Test strip
Model / Reference
17484
Primary DI / UDI-DI
05711383000109, 05714802400757
Basic UDI-DI
B-05711383000109, B-05714802400757
EMDN Code
W0102050205 Total human chorionic gonadotropin
Device Class
Class IVD devices for self-testing
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
CN-MF-000030045
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shenzhen GLD Biotechnology Ltd.

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 (2)

  • EUDAMED 2d3918c3-0fc2-493f-bb2c-107444e501f1 61 fields · synced 22 Oct 2026
  • EUDAMED 05714802400757|B-05714802400757 61 fields · synced 19 May 2026