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Alinity 04U7302

by Abbott

Ref 04U7302

Alinity 04U7302 is a device classified as Class B in the EU and Class II in the US made by Abbott, registered in EUDAMED on 24 Oct 2026 (Basic UDI-DI 038074HQU0473US), cleared under FDA 510(k) K020469 on 4 Apr 2002 and listed in FDA GUDID since 16 Nov 2023 (UDI-DI 00380740151294), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K020469

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038074HQU0473US Basic UDI-DI 00380740151294UDI-DIDate24 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740151294 UDI-DI Date16 Nov 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK020469 Date4 Apr 2002DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 038074HQU0473US registered 24 Oct 2026 Active
  • FDA 510(k) K020469 decided 4 Apr 2002 Active
  • FDA GUDID UDI-DI 00380740151294 listed 16 Nov 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K020469
  2. Listed FDA GUDID 00380740151294
  3. Registered EUDAMED 038074HQU0473US

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Alinity
Generic name
Full blood count IVD, calibrator
Model / Ref / Catalog
04U7302
Primary DI / UDI-DI
00380740151294
Basic UDI-DI
038074HQU0473US
FDA product code
KRY, KRX, KSA, KRZ
EMDN code
W0103010507 Whole blood calibrators
GMDN term
Full blood count IVD, calibrator
Device class
Class B EUDAMED
Class II GUDID
Regulation number
864.8175, 864.8150, 864.8185, 864.8165
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: Full blood count IVD, calibrator

Cleared under the same submission (K020469)

Similar devices in this category

Other devices filed under WHOLE BLOOD CALIBRATORS.

Other devices from Abbott

See all devices from Abbott →

Properties

  • Contains human tissues or cells
  • IVD kit
  • Professional testing
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)