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Alinity 02R5250

by Abbott Laboratories

Ref 02R5250

Alinity 02R5250 is a device classified as Class A in the EU and Class I in the US made by Abbott Laboratories, registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI 038074AIR0252L8) and listed in FDA GUDID since 3 Oct 2018 (UDI-DI 00380740156824), 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 Number038074AIR0252L8 Basic UDI-DI 00380740156824UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740156824 UDI-DI Date3 Oct 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074AIR0252L8 registered 26 Oct 2026 Active
  • FDA GUDID UDI-DI 00380740156824 listed 3 Oct 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740156824
  2. Registered EUDAMED 038074AIR0252L8

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  • Withdrawn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
Multiple clinical chemistry analyser IVD, laboratory
Model / Ref / Catalog
02R5250
Primary DI / UDI-DI
00380740156824
Basic UDI-DI
038074AIR0252L8
FDA product code
JJE
EMDN code
W0201020185 Automated immunochemistry analysers - consumables
GMDN term
Multiple clinical chemistry analyser IVD, laboratory
Device class
Class A EUDAMED
Class I GUDID
Regulation number
862.2160
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class A
GUDID
Class I

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

Related devices

Category: Multiple clinical chemistry analyser IVD, laboratory

Similar devices in this category

Other devices filed under AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES.

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Properties

  • Professional testing
  • IVD instrument
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)