Skip to content

Alinity 04T8830

by Abbott Ireland

Ref 04T8830

Alinity 04T8830 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 038074ACT0488KF) and listed in FDA GUDID since 15 Apr 2025 (UDI-DI 00380740158125), 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 Number038074ACT0488KF Basic UDI-DI 00380740158125UDI-DIDate18 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740158125 UDI-DI Date15 Apr 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074ACT0488KF registered 18 Aug 2026 Active
  • FDA GUDID UDI-DI 00380740158125 listed 15 Apr 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740158125
  2. Registered EUDAMED 038074ACT0488KF

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  • Withdrawn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
Total cholesterol lipid IVD, kit, spectrophotometry
Device name
Cholesterol2
Model / Ref / Catalog
04T8830
Primary DI / UDI-DI
00380740158125
Basic UDI-DI
038074ACT0488KF
FDA product code
CHH
EMDN code
W01010205 Cholesterol
GMDN term
Total cholesterol lipid IVD, kit, spectrophotometry
Device class
Class B EUDAMED
Class I GUDID
Regulation number
862.1175
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: Total cholesterol lipid IVD, kit, spectrophotometry

Similar devices in this category

Other devices filed under CHOLESTEROL.

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
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)