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Lyse for Hematology Analyzers Use

by Labnovation Technologies, Inc. China EUDAMED

Ref L-1740020

EMDN W01019001

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69383846XQ064Y2 Basic UDI-DIDate22 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
L-1740020
Primary DI / UDI-DI
06938384612769
Basic UDI-DI
69383846XQ064Y2
Direct Marketing DI
06938384612769
EMDN Code
W01019001 Buffers (unassignable), supplem. reagents, etc (cc)
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000015953
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Labnovation Technologies, Inc.

See all devices from Labnovation Technologies, Inc. →

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 2d550a50-6d36-447a-aaef-60aa740df7b0 61 fields · synced 22 Oct 2026