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Architect 04T3020

by Abbott Ireland

Ref 04T3020

Architect 04T3020 is a device classified as Class B in the EU and Class I in the US made by Abbott Ireland, registered in EUDAMED on 18 Aug 2026 (Basic UDI-DI 038074ART0430QK) and listed in FDA GUDID since 24 Jan 2024 (UDI-DI 00380740158392), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038074ART0430QK Basic UDI-DI 00380740158392UDI-DIDate18 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740158392 UDI-DI Date24 Jan 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074ART0430QK registered 18 Aug 2026 Active
  • FDA GUDID UDI-DI 00380740158392 listed 24 Jan 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740158392
  2. Registered EUDAMED 038074ART0430QK

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  • Withdrawn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
Lactate IVD, kit, spectrophotometry
Device name
Lactic Acid2
Model / Ref / Catalog
04T3020
Primary DI / UDI-DI
00380740158392
Basic UDI-DI
038074ART0430QK
FDA product code
KHP
EMDN code
W01010218 Lactate
GMDN term
Lactate IVD, kit, spectrophotometry
Device class
Class B EUDAMED
Class I GUDID
Regulation number
862.1450
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: Lactate IVD, kit, spectrophotometry

Similar devices in this category

Other devices filed under LACTATE.

Other devices from Abbott Ireland

See all devices from Abbott Ireland →

Properties

  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
  • New device
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (15, all answered No)