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Alinity

by Abbott Ireland, Diagnostics Division 74 variants

Ref 07P9022

Alinity (07P9022) is a Class C device made by Abbott Ireland Diagnostics Division, registered in EUDAMED on 24 Oct 2026 (Basic UDI-DI 038074AIP0790LK), active as of 7 Nov 2026.

Active European Union

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number038074AIP0790LK Basic UDI-DI 00380740216566UDI-DIDate24 Oct 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device name
Alinity i AFP
Model / reference
07P9022
Primary DI / UDI-DI
00380740216566
Basic UDI-DI
038074AIP0790LK
EMDN code
W0102039001 Alphafetoprotein
Device class
Class C
EU registration type
Standard device
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
IE-MF-000009849

Similar devices in this category

Other devices filed under ALPHAFETOPROTEIN.

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Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
Other properties (8, all answered No)