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Alinity 07P6230

by Abbott Ireland Diagnostics

Part of a family of 7 devices: see the family page

Ref 07P6230

Alinity 07P6230 is a device classified as Class C in the EU and Class II in the US made by Abbott Ireland Diagnostics, registered in EUDAMED on 19 Aug 2026 (Basic UDI-DI 038074AIP0762LE) and listed in FDA GUDID since 31 Dec 2018 (UDI-DI 00380740130862), 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 Number038074AIP0762LE Basic UDI-DI 00380740130862UDI-DIDate19 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740130862 UDI-DI Date31 Dec 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074AIP0762LE registered 19 Aug 2026 Active
  • FDA GUDID UDI-DI 00380740130862 listed 31 Dec 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740130862
  2. Registered EUDAMED 038074AIP0762LE

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  • Withdrawn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
Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay
Device name
Alinity i CEA
Model / Ref / Catalog
07P6230
Primary DI / UDI-DI
00380740130862
Basic UDI-DI
038074AIP0762LE
FDA product code
DHX
EMDN code
W05039080 Devices for samples analyses - other accessories
GMDN term
Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay
Device class
Class C EUDAMED
Class II GUDID
Regulation number
866.6010
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.

Related devices

Category: Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay

Similar devices in this category

Other devices filed under DEVICES FOR SAMPLES ANALYSES - OTHER ACCESSORIES.

Other devices from Abbott Ireland Diagnostics

See all devices from Abbott Ireland Diagnostics →

Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)