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CaseManager DX

by 3DHISTECH Kft. Hungary EUDAMED

Ref DX-CASEM-2, DX-CASEM-1

EMDN W0202050392

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number599957147155SE Basic UDI-DIDate26 May 2023RegisteredStatusActive

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
DX-CASEM-2, DX-CASEM-1
Primary DI / UDI-DI
05999571470303, 05999571470297
Basic UDI-DI
599957147155SE
EMDN Code
W0202050392 Laboratory instruments for microscopic investigations - IVD medical device software
Device Class
Class A
Special Device Type
Software
Market of Registration
Hungary

Manufacturer details

EUDAMED SRN
HU-MF-000014337

Other devices from 3DHISTECH Kft.

See all devices from 3DHISTECH Kft. →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED af59e5b5-bb54-4a56-9bb2-ca1ed0e62598 61 fields · synced 22 Oct 2026
  • EUDAMED 05999571470297|599957147155SE 61 fields · synced 17 May 2026