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Autolyse ABX

by Labex Reagens AB Sweden EUDAMED

Ref LY060

EMDN W01030199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number73501450010011001SJ Basic UDI-DIDate6 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

Device Name
Diluent CD
Model / Reference
LY060
Primary DI / UDI-DI
07350145000209
Basic UDI-DI
73501450010011001SJ
Direct Marketing DI
07350145000209
EMDN Code
W01030199 Haematology reagents - other
Device Class
Class A
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000048594

Other devices from Labex Reagens AB

See all devices from Labex Reagens AB →

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 a08ddbb1-9f4c-4397-a5b2-10b5aac9a18e 61 fields · synced 22 Oct 2026