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Architect 2K43-01

by Abbott Ireland Diagnostics

Ref 02K4301

Architect 2K43-01 (02K4301) is a device classified as Class C in the EU and Class II in the US made by Abbott Ireland Diagnostics, registered in EUDAMED on 15 Aug 2026 (Basic UDI-DI 038074ARK0243MF) and listed in FDA GUDID since 6 Jun 2016 (UDI-DI 00380740003272), 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 Number038074ARK0243MF Basic UDI-DI 00380740003272UDI-DIDate15 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740003272 UDI-DI Date6 Jun 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074ARK0243MF registered 15 Aug 2026 Active
  • FDA GUDID UDI-DI 00380740003272 listed 6 Jun 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740003272
  2. Registered EUDAMED 038074ARK0243MF

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  • Withdrawn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
Myoglobin IVD, calibrator
Device name
ARCHITECT STAT Myoglobin
Model / Ref / Catalog
02K4301, 2K43-01
Primary DI / UDI-DI
00380740003272
Basic UDI-DI
038074ARK0243MF
FDA product code
JIS, DDR
EMDN code
W0102152204 Cardiac marker standards and calibrators
GMDN term
Myoglobin IVD, calibrator
Device class
Class C EUDAMED
Class II GUDID
Regulation number
862.1150, 866.5680
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
02K4301
GUDID
2K43-01
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: Myoglobin IVD, calibrator

Similar devices in this category

Other devices filed under CARDIAC MARKER STANDARDS AND CALIBRATORS.

Other devices from Abbott Ireland Diagnostics

See all devices from Abbott Ireland Diagnostics →

Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (16, all answered No)