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Architect 04T0220

by Abbott Ireland

Ref 04T0220

Architect 04T0220 is a device classified as Class B in the EU and Class I in the US made by Abbott Ireland, registered in EUDAMED on 25 Oct 2026 (Basic UDI-DI 038074ART0402QE) and listed in FDA GUDID since 20 Oct 2023 (UDI-DI 00380740160692), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038074ART0402QE Basic UDI-DI 00380740160692UDI-DIDate25 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740160692 UDI-DI Date20 Oct 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074ART0402QE registered 25 Oct 2026 Active
  • FDA GUDID UDI-DI 00380740160692 listed 20 Oct 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740160692
  2. Registered EUDAMED 038074ART0402QE

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  • Withdrawn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
Iron IVD, kit, spectrophotometry
Device name
Iron2
Model / Ref / Catalog
04T0220
Primary DI / UDI-DI
00380740160692
Basic UDI-DI
038074ART0402QE
FDA product code
JIY
EMDN code
W01010216 Iron (cc)
GMDN term
Iron IVD, kit, spectrophotometry
Device class
Class B EUDAMED
Class I GUDID
Regulation number
862.1410
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class B
GUDID
Class I

Device class is stated on each registry's own scale: Class B 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: Iron IVD, kit, spectrophotometry

Similar devices in this category

Other devices filed under IRON (CC).

Other devices from Abbott Ireland

See all devices from Abbott Ireland →

Properties

  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)