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Architect 02K4524

by Abbott

Part of a family of 9 devices: see the family page

Ref 02K4524

Architect 02K4524 is a device classified as Class C in the EU and Class II in the US made by Abbott, registered in EUDAMED on 25 Aug 2026 (Basic UDI-DI 038074ARK0245MK) and listed in FDA GUDID since 21 Jan 2019 (UDI-DI 00380740145361), 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 Number038074ARK0245MK Basic UDI-DI 00380740145361UDI-DIDate25 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740145361 UDI-DI Date21 Jan 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074ARK0245MK registered 25 Aug 2026 Active
  • FDA GUDID UDI-DI 00380740145361 listed 21 Jan 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740145361
  2. Registered EUDAMED 038074ARK0245MK

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  • Withdrawn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
Architect
Generic name
Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
Device name
Architect Ca 125 II
Model / Ref / Catalog
02K4524
Primary DI / UDI-DI
00380740145361
Basic UDI-DI
038074ARK0245MK
FDA product code
LTK
EMDN code
W0102030106 Cancer antigen 125
GMDN term
Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
Device class
Class C EUDAMED
Class II GUDID
Regulation number
866.6010
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: Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay

Similar devices in this category

Other devices filed under CANCER ANTIGEN 125.

Other devices from Abbott

See all devices from Abbott →

Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)