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AlinIQ 03R8965

by ABBOTT S.r.l.

Ref 03R8965

AlinIQ 03R8965 is a device classified as Class A in the EU and Class I in the US made by ABBOTT S.r.l., registered in EUDAMED on 10 Sep 2026 (Basic UDI-DI 038074IQR0389UL) and listed in FDA GUDID since 28 Mar 2024 (UDI-DI 00380740212575), active as of 12 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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038074IQR0389UL Basic UDI-DI 00380740212575UDI-DIDate10 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740212575 UDI-DI Date28 Mar 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074IQR0389UL registered 10 Sep 2026 Active
  • FDA GUDID UDI-DI 00380740212575 listed 28 Mar 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740212575
  2. Registered EUDAMED 038074IQR0389UL

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  • Withdrawn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
AlinIQ
Generic name
Laboratory instrument/analyser application software IVD
Model / Ref / Catalog
03R8965
Primary DI / UDI-DI
00380740212575
Basic UDI-DI
038074IQR0389UL
FDA product code
JQP
EMDN code
W05039080 Devices for samples analyses - other accessories
GMDN term
Laboratory instrument/analyser application software IVD
Device class
Class A EUDAMED
Class I GUDID
Regulation number
862.2100
Special device type
Software
EU registration type
Standard device
EU market of registration
France
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: Laboratory instrument/analyser application software IVD

Similar devices in this category

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

Other devices from ABBOTT S.r.l.

See all devices from ABBOTT S.r.l. →

Properties

  • Professional testing
  • Premarket exempt
  • Lot / batch number
Other properties (23, all answered No)