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4DS Dana

by Dana Tajhiz Aria Iran EUDAMED

Ref DTA-SYS-81DS-42mlModel 4DS-LYSER

EMDN W0103010199

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6262234DS-LYSERUA Basic UDI-DIDate22 Oct 2025RegisteredStatusActive

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 4DS Reagent for Hematology Analyzers (Sysmex compatible)
Model / Reference
4DS-LYSER, DTA-SYS-81DS-42ml
Primary DI / UDI-DI
06262238886205
Basic UDI-DI
6262234DS-LYSERUA
EMDN Code
W0103010199 Reagents for (automated) haematology analyzer - other
Device Class
Class A
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
IR-MF-000049659
Authorised representative
Medisol Technologies S.L. ES-AR-000044726

Other devices from Dana Tajhiz Aria

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Companion Diagnostics
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED bcc7d548-691f-43d8-8325-cfca1fca2374 61 fields · synced 24 Oct 2026