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DxDATA

by DRG Instruments GmbH Germany EUDAMED

Ref DXD-0001Model DxDATA Automated Chemiluminescent Immunoassay Analyzing System EMDN W0299

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number4048474DXD-0001FX Basic UDI-DIDate28 May 2026RegisteredStatusActive

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  • Withdrawn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 23 Oct 2026

Device Name
DxDATA Automated Chemiluminescent Immunoassay Analyzing System
Model / Reference
DxDATA Automated Chemiluminescent Immunoassay Analyzing System, DXD-0001
Primary DI / UDI-DI
04048474000016
Basic UDI-DI
4048474DXD-0001FX
EMDN Code
W0299 IVD instruments - other
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000024828

Other devices from DRG Instruments GmbH

Properties & raw data

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

Sources (1)

  • EUDAMED 332b1450-dfab-464e-aae6-8d667d28c497 61 fields · synced 23 Oct 2026