Skip to content

Pregnancy HCG test

by Shenzhen GLD Biotechnology Ltd. China EUDAMED

Ref 2018240024503Model midstream, Midstream EMDN W0102050205

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06940792402719 Basic UDI-DIDate11 Feb 2026RegisteredStatusActive

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  • Withdrawn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
Human chorionic gonadotropin (HCG) rapid test (Colloidal gold method)
Model / Reference
midstream, 2018240024503
Primary DI / UDI-DI
06940792402719, 06940792402726
Basic UDI-DI
B-06940792402719, B-06940792402726
EMDN Code
W0102050205 Total human chorionic gonadotropin
Device Class
Class IVD devices for self-testing
Market of Registration
Finland

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 d93e6ec7-6934-4135-9b7a-9a3151cedd78 61 fields · synced 22 Oct 2026
  • EUDAMED 06940792402726|B-06940792402726 61 fields · synced 19 May 2026