Skip to content

LYA-2 Lyse

by Gmt SARL France EUDAMED

Ref OX58L0202Model LYA-2 Lyse 580.51, LYA-2 Lyse

EMDN W0103010105

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number3770028922OX58L0002ZD Basic UDI-DIDate4 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Lya-2
Model / Reference
LYA-2 Lyse 580.51, LYA-2 Lyse, OX58L0202
Primary DI / UDI-DI
03770028922833
Basic UDI-DI
3770028922OX58L0002ZD
EMDN Code
W0103010105 Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)
Device Class
Class A
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000025248

Other devices from Gmt SARL

See all devices from Gmt SARL →

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 0f37a96f-41d4-4441-bb12-2cd112962130 61 fields · synced 24 Oct 2026