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GeneSign LH FIA

by GeneSign Biotech (Xiamen)Co., Ltd. China EUDAMED

Ref GS121002C01Model 1 test/kit EMDN W0102160304

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06977903340332 Basic UDI-DIDate20 Aug 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  • Withdrawn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
Lh Fia
Model / Reference
1 test/kit, GS121002C01
Primary DI / UDI-DI
06977903340332
Basic UDI-DI
B-06977903340332
EMDN Code
W0102160304 Lh - rt & poc
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000044463
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from GeneSign Biotech (Xiamen)Co., Ltd.

See all devices from GeneSign Biotech (Xiamen)Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 06977903340332|B-06977903340332 61 fields · synced 25 Oct 2026