Skip to content

Architect

by Abbott Ireland, Diagnostics Division 7 variants

Ref 06C5482

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number038074SLI0002T5 Basic UDI-DI 00380740100940UDI-DIDate17 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
ARCHITECT System Solutions
Model / Reference
06C5482
Primary DI / UDI-DI
00380740100940
Basic UDI-DI
038074SLI0002T5
EMDN Code
W0201020185 Automated immunochemistry analysers - consumables
Device Class
Class A
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
IE-MF-000009849

Other devices from Abbott Ireland Diagnostics Division

See all devices from Abbott Ireland Diagnostics Division →

Properties

  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Professional Testing
  • Surgical Instrument

Other properties (6)

  • Sterile: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No