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Pregnancy HCG test

by Shenzhen GLD Biotechnology Ltd. China EUDAMED

Ref 20260501Model strip EMDN W0102160302

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06429830209218 Basic UDI-DIDate27 May 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  • Withdrawn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

Model / Reference
strip, 20260501
Primary DI / UDI-DI
06429830209218
Basic UDI-DI
B-06429830209218
EMDN Code
W0102160302 Hcg - rt & poc
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 06429830209218|B-06429830209218 61 fields · synced 25 Oct 2026