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Hexalis Calcul

by Dedalus HealthCare France France EUDAMED

Ref Hexalis Calcul

EMDN W02069082

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number3770027563IVDHEXAKS Basic UDI-DIDate13 Sep 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

Device Name
Hexalis Calcul
Model / Reference
Hexalis Calcul
Primary DI / UDI-DI
03770027563013
Basic UDI-DI
3770027563IVDHEXAKS
Direct Marketing DI
03770027563013
EMDN Code
W02069082 Various sample processing instruments - software accessories
Device Class
Class A
Special Device Type
Software
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000025253

Other devices from Dedalus HealthCare France

  • Dlce

    Class A

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 (1)

  • EUDAMED 308c92ea-b589-478d-b0eb-9d260d7a38a2 61 fields · synced 22 Oct 2026