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Genedrive® System

by Genedrive Diagnostics Ltd. United Kingdom EUDAMED

Ref GS-002 V4.0 EMDN W02050301

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number506065486GS-00X2F Basic UDI-DIDate2 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
GS-002 V4.0
Primary DI / UDI-DI
05060654860172
Basic UDI-DI
506065486GS-00X2F
EMDN Code
W02050301 Nucleic acid testing apparatuses - rapid and point of care tests
Device Class
Class A
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
GB-MF-000012810
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Genedrive Diagnostics Ltd

See all devices from Genedrive Diagnostics Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED e2ad3b1c-6db7-45fe-8bcf-3c4741f2efca 61 fields · synced 24 Oct 2026