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Genexpath

by Genexpath EUDAMED

Active European Union

Ref GEP-LS08, GEP-SF24, GEP-LS16, GEP-SF08Model LymphoSign 8U, SarcomaFusion 24U, LymphoSign 16U, SarcomaFusion 8U

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-03770026953006 Basic UDI-DIDate9 Oct 2025RegisteredStatusActive

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  • Withdrawn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

Device Name
LymphoSign 8U
SarcomaFusion 24U
LymphoSign 16U
SarcomaFusion 8U
Model / Reference
LymphoSign 8U, GEP-LS08, SarcomaFusion 24U, GEP-SF24, LymphoSign 16U, GEP-LS16, SarcomaFusion 8U, GEP-SF08
Primary DI / UDI-DI
03770026953006, 03770026953068, 03770026953013, 03770026953044
Basic UDI-DI
B-03770026953006, B-03770026953068, B-03770026953013, B-03770026953044
EMDN Code
W01060299 Tests for acquired genetic or chromosomal alterations - other
Device Class
Class IVD General
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000029325

Other devices from Genexpath

Properties

  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No