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Alinity 09P5624

by Abbott Ireland

Ref 09P5624

Alinity 09P5624 is a device classified as Class B in the EU and Class II in the US made by Abbott Ireland, registered in EUDAMED on 23 Aug 2026 (Basic UDI-DI 038074LFD0021KD) and listed in FDA GUDID since 13 May 2021 (UDI-DI 00380740170172), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038074LFD0021KD Basic UDI-DI 00380740170172UDI-DIDate23 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740170172 UDI-DI Date13 May 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074LFD0021KD registered 23 Aug 2026 Active
  • FDA GUDID UDI-DI 00380740170172 listed 13 May 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740170172
  2. Registered EUDAMED 038074LFD0021KD

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  • Withdrawn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
Complement components C3/C3c IVD, kit, nephelometry/turbidimetry
Device name
Alinity c Complement C3
Model / Ref / Catalog
09P5624
Primary DI / UDI-DI
00380740170172
Basic UDI-DI
038074LFD0021KD
FDA product code
CZW
EMDN code
W0102010203 Complement component c3/c3c
GMDN term
Complement components C3/C3c IVD, kit, nephelometry/turbidimetry
Device class
Class B EUDAMED
Class II GUDID
Regulation number
866.5240
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 B
GUDID
Class II

Device class is stated on each registry's own scale: Class B 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: Complement components C3/C3c IVD, kit, nephelometry/turbidimetry

Similar devices in this category

Other devices filed under COMPLEMENT COMPONENT C3/C3C.

Other devices from Abbott Ireland

See all devices from Abbott Ireland →

Properties

  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)