Skip to content

Alinity mp 09N65-23

by Abbott Molecular

Ref 09N65-23

Alinity mp 09N65-23 is a device classified as Class A in the EU and Class I in the US made by Abbott Molecular, registered in EUDAMED on 9 Oct 2026 (Basic UDI-DI 0884999AMN0057WR) and listed in FDA GUDID since 28 May 2025 (UDI-DI 00884999051522), active as of 23 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0884999AMN0057WR Basic UDI-DI 00884999051522UDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00884999051522 UDI-DI Date28 May 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0884999AMN0057WR registered 9 Oct 2026 Active
  • FDA GUDID UDI-DI 00884999051522 listed 28 May 2025 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

2 dated events

  1. Listed FDA GUDID 00884999051522
  2. Registered EUDAMED 0884999AMN0057WR

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  • Withdrawn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 mp
Generic name
Microplate IVD
Model / Ref / Catalog
09N65-23
Primary DI / UDI-DI
00884999051522
Basic UDI-DI
0884999AMN0057WR
FDA product code
JQW
EMDN code
W02060185 Robotic sample processing systems - consumables
GMDN term
Microplate IVD
Device class
Class A EUDAMED
Class I GUDID
Regulation number
862.2750
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: Microplate IVD

Similar devices in this category

Other devices filed under ROBOTIC SAMPLE PROCESSING SYSTEMS.

Other devices from Abbott Molecular

See all devices from Abbott Molecular →

Properties

  • Single use
  • Professional testing
  • Premarket exempt
  • Lot / batch number
Other properties (22, all answered No)