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Architect

by Abbott Ireland Diagnostics Division Ireland EUDAMED

Ref 04T1230

EMDN W01010204

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00380740165673 Basic UDI-DIDate18 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Urea Nitrogen2
Model / Reference
04T1230
Primary DI / UDI-DI
00380740165673
Basic UDI-DI
B-00380740165673
EMDN Code
W01010204 Urea/blood urea nitrogen
Device Class
Class IVD General
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
IE-MF-000010070

Other devices from Abbott Ireland Diagnostics Division

See all devices from Abbott Ireland Diagnostics Division →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 00380740165673|B-00380740165673 61 fields · synced 24 Oct 2026