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Luteinizing hormone Rapid Test Kit (Colloidal Gold)

by Jiangsu Konsung Medical Technology Co., Ltd. China EUDAMED

Ref FLH-101G-1 EMDN W0102160304

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975132463419 Basic UDI-DIDate7 Jun 2022RegisteredStatusActive

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  • Withdrawn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 24 Oct 2026

Device Name
Luteinizing hormone Rapid Test Kit (Colloidal Gold)
Model / Reference
FLH-101G-1
Primary DI / UDI-DI
06975132463419
Basic UDI-DI
B-06975132463419
EMDN Code
W0102160304 Lh - rt & poc
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000004533
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Jiangsu Konsung Medical Technology Co., Ltd.

See all devices from Jiangsu Konsung Medical Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Near-Patient Testing
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED aace2721-ba5f-4446-9ad3-f6fb9d3e2763 61 fields · synced 24 Oct 2026