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Alinity m 09N26-015

by Abbott Molecular

Ref 09N26-015

Alinity m 09N26-015 is a barcode reader (EU IVDR Class A; FDA Class II; FDA product code OOI, real time Nucleic acid amplification system) made by Abbott Molecular, registered in EUDAMED on 9 Oct 2026 (Basic UDI-DI 0884999AMN0036WH) and listed in FDA GUDID since 29 Apr 2020 (UDI-DI 00884999047457), active as of 24 Oct 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0884999AMN0036WH Basic UDI-DI 00884999047457UDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00884999047457 UDI-DI Date29 Apr 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0884999AMN0036WH registered 9 Oct 2026 Active
  • FDA GUDID UDI-DI 00884999047457 listed 29 Apr 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00884999047457
  2. Registered EUDAMED 0884999AMN0036WH

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  • Withdrawn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 m
Generic name
Barcode reader
Model / Ref / Catalog
09N26-015
Primary DI / UDI-DI
00884999047457
Basic UDI-DI
0884999AMN0036WH
FDA product code
OOI
EMDN code
W0580 IVD general use consumables devices - other accessories
GMDN term
Barcode reader
Device class
Class A EUDAMED
Class II GUDID
Regulation number
862.2570
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 II

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

Related devices

Category: Barcode reader

Similar devices in this category

Other devices filed under IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES.

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Properties

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