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Architect

by Abbott Ireland Diagnostics Division Ireland EUDAMED

Ref 01P3701

EMDN W0102152208

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number038074LGF0009LS Basic UDI-DIDate15 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
ARCHITECT Urine NGAL
Model / Reference
01P3701
Primary DI / UDI-DI
00380740001858
Basic UDI-DI
038074LGF0009LS
EMDN Code
W0102152208 Standards and calibrators for individual and specific hormones /proteins
Device Class
Class C
Market of Registration
Germany

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
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 00380740001858|038074LGF0009LS 61 fields · synced 24 Oct 2026