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ComboLab AltiX AI.i

by GE Medical Systems Information Technologies, Inc.

Ref 2400000-005

ComboLab AltiX AI.i (2400000-005) is a device classified as Class IIa in the EU and Class II in the US made by GE Medical Systems Information Technologies, Inc., cleared under FDA 510(k) K243540 on 12 Dec 2024, registered in EUDAMED on 31 Aug 2022 (Basic UDI-DI 8406821BUG00282HJ) and listed in FDA GUDID since 5 May 2025 (UDI-DI 00195278935687), active as of 23 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K243540

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00195278935687 UDI-DI Date5 May 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK243540 Date12 Dec 2024DecidedStatusActive
European UnionCE/MDR EUDAMED Number8406821BUG00282HJ Basic UDI-DI 00195278935687UDI-DIDate31 Aug 2022RegisteredStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K243540 decided 12 Dec 2024 Active
  • EUDAMED Basic UDI-DI 8406821BUG00282HJ registered 31 Aug 2022 Active
  • FDA GUDID UDI-DI 00195278935687 listed 5 May 2025 Listed

Timeline

3 dated events

  1. Registered EUDAMED 8406821BUG00282HJ
  2. Cleared FDA 510(k) K243540
  3. Listed FDA GUDID 00195278935687

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
ComboLab AltiX AI.i EUDAMED
ComboLab GUDID
Generic name
Cardiac electrophysiology analysis system
Model / Ref / Catalog
2400000-005, AltiX AI.i
Primary DI / UDI-DI
00195278935687
Basic UDI-DI
8406821BUG00282HJ
Direct marketing DI
00195278935687
510(k) Number
FDA product code
DQK
EMDN code
Z12050702, Z12050703
GMDN term
Cardiac electrophysiology analysis system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.1425
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
2400000-005
GUDID
AltiX AI.i
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Cardiac catheterization monitoring systemCardiac electrophysiology analysis system

Cleared under the same submission (K243540)

Similar devices in this category

Other devices filed under POLYGRAPHY SYSTEMS FOR HAEMODYNAMIC STUDIES.

Other devices from GE Medical Systems Information Technologies, Inc.

See all devices from GE Medical Systems Information Technologies, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)