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Dnlab IVD Core

by Dedalus Italia SpA Italy EUDAMED

Ref DNLAB IVD CORE EMDN W02079092

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number805572803DNLABIVDCORES6 Basic UDI-DIDate22 Feb 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
DNLAB IVD CORE
Primary DI / UDI-DI
08055728030060, 08055728030480
Basic UDI-DI
805572803DNLABIVDCORES6
Direct Marketing DI
08055728030060
08055728030480
EMDN Code
W02079092 Various general purpose IVD instruments - IVD medical device software
Device Class
Class A
Special Device Type
Software
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000009127

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Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED 542d3b09-ee54-4f02-9f7c-7432875029d5 61 fields · synced 22 Oct 2026
  • EUDAMED 08055728030480|805572803DNLABIVDCORES6 61 fields · synced 17 May 2026