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Pregnancy HCG test

by Shenzhen GLD Biotechnology Ltd. China EUDAMED

Ref 2018240024502Model Cassette EMDN W0102050205

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06940792402702 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  • Withdrawn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 25 Oct 2026

Device Name
Human chorionic gonadotropin (HCG) rapid test (Colloidal gold method)
Model / Reference
Cassette, 2018240024502
Primary DI / UDI-DI
06940792402702
Basic UDI-DI
B-06940792402702
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 (1)

  • EUDAMED 45f97a16-da29-4c5a-9a63-5f0dced21300 61 fields · synced 25 Oct 2026