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Alinity 06P1388

by Abbott Ireland Diagnostics

Ref 06P1388

Alinity 06P1388 is a device classified as Class A (EU), Not classified (US) made by Abbott Ireland Diagnostics, registered in EUDAMED on 17 Aug 2026 (Basic UDI-DI 038074MPP0613V3) and listed in FDA GUDID since 26 Jul 2019 (UDI-DI 00380740118181), 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038074MPP0613V3 Basic UDI-DI 00380740118181UDI-DIDate17 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740118181 UDI-DI Date26 Jul 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074MPP0613V3 registered 17 Aug 2026 Active
  • FDA GUDID UDI-DI 00380740118181 listed 26 Jul 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740118181
  2. Registered EUDAMED 038074MPP0613V3

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  • Withdrawn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
Buffered wash solution IVD
Model / Ref / Catalog
06P1388
Primary DI / UDI-DI
00380740118181
Basic UDI-DI
038074MPP0613V3
FDA product code
MZA
EMDN code
W05039080 Devices for samples analyses - other accessories
GMDN term
Buffered wash solution IVD
Device class
Class A EUDAMED
N GUDID
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
N

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

Related devices

Category: Buffered wash solution IVD

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

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Properties

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