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Architect 1E64-03

by Abbott

Ref 01E6403Model 1E64-03

Architect 1E64-03 (01E6403) is a device classified as IVD General (EU), Class II (US) made by Abbott, registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI B-00380740161378) and listed in FDA GUDID since 18 Sep 2020 (UDI-DI 00380740161378), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE IVDD

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/IVDD EUDAMED NumberB-00380740161378 Basic UDI-DI 00380740161378UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740161378 UDI-DI Date18 Sep 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00380740161378 registered 30 Oct 2026 Active
  • FDA GUDID UDI-DI 00380740161378 listed 18 Sep 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740161378
  2. Registered EUDAMED B-00380740161378

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Architect
Generic name
Carbon dioxide (CO2) IVD, calibrator
Model / Ref / Catalog
1E64-03, 01E6403
Primary DI / UDI-DI
00380740161378
Basic UDI-DI
B-00380740161378
FDA product code
JIX
EMDN code
W0101050302 Calibrators single component (cc)
GMDN term
Carbon dioxide (CO2) IVD, calibrator
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
862.1150
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class II

Device class is stated on each registry's own scale: Class IVD General 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: Carbon dioxide (CO2) IVD, calibrator

Similar devices in this category

Other devices filed under CALIBRATORS SINGLE COMPONENT (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)