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Lyse 360.03

by Gmt SARL France EUDAMED

Ref OX36L0300Model Lyse 360.05, Lyse 360.03

EMDN W0103010105

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number3770028922OX36L0000XD Basic UDI-DIDate3 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
Lyse 360
Model / Reference
Lyse 360.05, Lyse 360.03, OX36L0300
Primary DI / UDI-DI
03770028922925
Basic UDI-DI
3770028922OX36L0000XD
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 28bc2861-e519-421f-a9a9-dc8804e147ce 61 fields · synced 24 Oct 2026