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Alinity 04U0920

by Abbott Ireland

Ref 04U0920

Alinity 04U0920 is a device classified as Class C in the EU and Class I in the US made by Abbott Ireland, registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI 038074ACU0409K4) and listed in FDA GUDID since 12 Jul 2022 (UDI-DI 00380740158378), 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 Number038074ACU0409K4 Basic UDI-DI 00380740158378UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740158378 UDI-DI Date12 Jul 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074ACU0409K4 registered 26 Oct 2026 Active
  • FDA GUDID UDI-DI 00380740158378 listed 12 Jul 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740158378
  2. Registered EUDAMED 038074ACU0409K4

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  • Withdrawn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
Alinity
Generic name
Uric acid IVD, kit, spectrophotometry
Device name
Uric Acid2
Model / Ref / Catalog
04U0920
Primary DI / UDI-DI
00380740158378
Basic UDI-DI
038074ACU0409K4
FDA product code
KNK
EMDN code
W01010232 Uric acid
GMDN term
Uric acid IVD, kit, spectrophotometry
Device class
Class C EUDAMED
Class I GUDID
Regulation number
862.1775
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 C
GUDID
Class I

Device class is stated on each registry's own scale: Class C 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: Uric acid IVD, kit, spectrophotometry

Similar devices in this category

Other devices filed under URIC ACID.

Other devices from Abbott Ireland

See all devices from Abbott Ireland →

Properties

  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)