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Alinity

by Abbott Ireland, Diagnostics Division 74 variants

Ref 07P4232

Alinity (07P4232) is a Class C device made by Abbott Ireland Diagnostics Division, registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI 038074AIP0742L8), 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 Number038074AIP0742L8 Basic UDI-DI 00380740129804UDI-DIDate26 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  • Withdrawn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 CMV IgG
Model / reference
07P4232
Primary DI / UDI-DI
00380740129804
Basic UDI-DI
038074AIP0742L8
EMDN code
W0105040203 Cmv igg
Device class
Class C
EU registration type
Standard device
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
IE-MF-000009849

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Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
Other properties (7, all answered No)