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Ovulation LH test

by Shenzhen GLD Biotechnology Ltd. China EUDAMED

Ref 20182400244003, 20260501Model Midstream, strip EMDN W0102050105

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06940792402689 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  • Withdrawn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
Luteinzing hormone test (colloidal gold immunochromatography).
Model / Reference
Midstream, 20182400244003, strip, 20260501
Primary DI / UDI-DI
06940792402689, 06429830209201
Basic UDI-DI
B-06940792402689, B-06429830209201
EMDN Code
W0102050105, W0102160304
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 98c12b86-651a-493c-a6b6-41b119dfbaae 61 fields · synced 22 Oct 2026
  • EUDAMED 06429830209201|B-06429830209201 61 fields · synced 14 Jun 2026