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Alinity 04T8220

by Abbott Ireland

Ref 04T8220

Alinity 04T8220 is a device classified as Class B in the EU and Class II in the US made by Abbott Ireland, registered in EUDAMED on 18 Aug 2026 (Basic UDI-DI 038074ACT0482K3) and listed in FDA GUDID since 15 Aug 2024 (UDI-DI 00380740155285), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038074ACT0482K3 Basic UDI-DI 00380740155285UDI-DIDate18 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740155285 UDI-DI Date15 Aug 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074ACT0482K3 registered 18 Aug 2026 Active
  • FDA GUDID UDI-DI 00380740155285 listed 15 Aug 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740155285
  2. Registered EUDAMED 038074ACT0482K3

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  • Withdrawn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
Albumin IVD, kit, spectrophotometry
Device name
Albumin BCP2
Model / Ref / Catalog
04T8220
Primary DI / UDI-DI
00380740155285
Basic UDI-DI
038074ACT0482K3
FDA product code
CJW
EMDN code
W01010201 Albumin (cc)
GMDN term
Albumin IVD, kit, spectrophotometry
Device class
Class B EUDAMED
Class II GUDID
Regulation number
862.1035
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 II

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

Related devices

Category: Albumin IVD, kit, spectrophotometry

Similar devices in this category

Other devices filed under ALBUMIN (CC).

Other devices from Abbott Ireland

See all devices from Abbott Ireland →

Properties

  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)