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Alinity 04T9730

by Abbott Ireland

Ref 04T9730

Alinity 04T9730 is a device classified as Class C in the EU and Class II in the US made by Abbott Ireland, registered in EUDAMED on 23 Oct 2026 (Basic UDI-DI 038074ACT0497KG) and listed in FDA GUDID since 15 Oct 2026 (UDI-DI 00380740155698), 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 Number038074ACT0497KG Basic UDI-DI 00380740155698UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740155698 UDI-DI Date15 Oct 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074ACT0497KG registered 23 Oct 2026 Active
  • FDA GUDID UDI-DI 00380740155698 listed 15 Oct 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740155698
  2. Registered EUDAMED 038074ACT0497KG

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  • Withdrawn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
Glucose IVD, kit, spectrophotometry
Model / Ref / Catalog
04T9730
Primary DI / UDI-DI
00380740155698
Basic UDI-DI
038074ACT0497KG
FDA product code
CFR
EMDN code
W01010213 Glucose
GMDN term
Glucose IVD, kit, spectrophotometry
Device class
Class C EUDAMED
Class II GUDID
Regulation number
862.1345
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 II

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

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Properties

  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
  • New device
  • Prescription use
  • Convenience kit
  • Lot / batch number
Other properties (18, all answered No)