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Alinity 08P7001

by Abbott

Ref 08P7001

Alinity 08P7001 is a device classified as Class C in the EU and Class II in the US made by Abbott, registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI 038074ACP0870J4) and listed in FDA GUDID since 31 May 2018 (UDI-DI 00380740121709), 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 Number038074ACP0870J4 Basic UDI-DI 00380740121709UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740121709 UDI-DI Date31 May 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074ACP0870J4 registered 26 Oct 2026 Active
  • FDA GUDID UDI-DI 00380740121709 listed 31 May 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740121709
  2. Registered EUDAMED 038074ACP0870J4

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  • Withdrawn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 electrolyte IVD, calibrator
Model / Ref / Catalog
08P7001
Primary DI / UDI-DI
00380740121709
Basic UDI-DI
038074ACP0870J4
FDA product code
JIX
EMDN code
W0101050301 Calibrators multicomponent (cc)
GMDN term
Multiple electrolyte IVD, calibrator
Device class
Class C EUDAMED
Class II GUDID
Regulation number
862.1150
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 C
GUDID
Class II

Device class is stated on each registry's own scale: Class C 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: Multiple electrolyte IVD, calibrator

Similar devices in this category

Other devices filed under CALIBRATORS MULTICOMPONENT (CC).

Other devices from Abbott

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Properties

  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)