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Architect 06E2365

by Abbott Ireland Diagnostics

Part of a family of 15 devices: see the family page

Ref 06E2365

Architect 06E2365 is a device classified as Class A in the EU and Class I in the US made by Abbott Ireland Diagnostics, registered in EUDAMED on 17 Aug 2026 (Basic UDI-DI 038074SLI0002T5) and listed in FDA GUDID since 31 Jul 2018 (UDI-DI 00380740009786), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038074SLI0002T5 Basic UDI-DI 00380740009786UDI-DIDate17 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740009786 UDI-DI Date31 Jul 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074SLI0002T5 registered 17 Aug 2026 Active
  • FDA GUDID UDI-DI 00380740009786 listed 31 Jul 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740009786
  2. Registered EUDAMED 038074SLI0002T5

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Architect
Generic name
Chemiluminescent immunoassay oxidizing reagent IVD
Device name
ARCHITECT System Solutions
Model / Ref / Catalog
06E2365
Primary DI / UDI-DI
00380740009786
Basic UDI-DI
038074SLI0002T5
FDA product code
JJE
EMDN code
W0201020185 Automated immunochemistry analysers - consumables
GMDN term
Chemiluminescent immunoassay oxidizing reagent IVD
Device class
Class A EUDAMED
Class I GUDID
Regulation number
862.2160
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class A
GUDID
Class I

Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Chemiluminescent immunoassay oxidizing reagent IVD

Similar devices in this category

Other devices filed under AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES.

Other devices from Abbott Ireland Diagnostics

See all devices from Abbott Ireland Diagnostics →

Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Professional testing
  • IVD instrument
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (16, all answered No)