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LYA-3 Lyse 580.1

by Gmt SARL France EUDAMED

Ref OX58L0010Model LYA-3 Lyse 580.1, LYA-3 Lyse EMDN W0103010105

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number3770028922OX58L0003ZF Basic UDI-DIDate4 Jun 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
Lya-3
Model / Reference
LYA-3 Lyse 580.1, LYA-3 Lyse, OX58L0010
Primary DI / UDI-DI
03770028922314
Basic UDI-DI
3770028922OX58L0003ZF
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 f145eb6f-9563-4bb3-8e95-997f49cb7e3a 61 fields · synced 24 Oct 2026