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Alinity

by Abbott Ireland, Diagnostics Division 2 variants

Part of a family of 9 devices: see the family page

Ref 06P1183

Alinity (06P1183) is a Class A device made by Abbott Ireland Diagnostics Division, registered in EUDAMED on 17 Aug 2026 (Basic UDI-DI 038074SLI0001T3), active as of 24 Oct 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number038074SLI0001T3 Basic UDI-DI 00380740188788UDI-DIDate17 Aug 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device name
Alinity i System Solutions
Model / reference
06P1183
Primary DI / UDI-DI
00380740188788
Basic UDI-DI
038074SLI0001T3
EMDN code
W0201020185 Automated immunochemistry analysers - consumables
Device class
Class A
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
IE-MF-000009849

Similar devices in this category

Other devices filed under AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES.

Other devices from Abbott Ireland Diagnostics Division

See all devices from Abbott Ireland Diagnostics Division →

Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Professional testing
  • IVD instrument
Other properties (8, all answered No)