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ECG app

by Apple Inc. 2 variants

Ref ECG app 2.XModel 2.X

ECG app (ECG app 2.X) is a device classified as Class IIa in the EU and Class II in the US made by Apple Inc., registered in EUDAMED on 14 Aug 2025 (Basic UDI-DI 0190199ECGApp2QP) and listed in FDA GUDID since 15 Dec 2020 (UDI-DI 00190199649286), active as of 22 Oct 2026.

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

CE MDR

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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0190199ECGApp2QP Basic UDI-DI 00190199649286UDI-DIDate14 Aug 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00190199649286 UDI-DI Date15 Dec 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0190199ECGApp2QP registered 14 Aug 2025 Active
  • FDA GUDID UDI-DI 00190199649286 listed 15 Dec 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00190199649286
  2. Registered EUDAMED 0190199ECGApp2QP

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
ECG 2.0 App
Generic name
Cardiopulmonary physiological parameter analysis software, professional-only
Device name
ECG app
Model / reference
2.X EUDAMED
ECG app 2.X EUDAMED
Feature Version 2.x GUDID
Primary DI / UDI-DI
00190199649286
Basic UDI-DI
0190199ECGApp2QP
Direct marketing DI
00190199649286
FDA product code
QDA
EMDN code
Z12050382 Electrocardiographs - software accessories
GMDN term
Cardiopulmonary physiological parameter analysis software, professional-only
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.2345
Special device type
Software
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
2.X
ECG app 2.X
GUDID
Feature Version 2.x
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.

Manufacturer details

EUDAMED SRN
US-MF-000013709
Authorised representative
Apple Distribution International Limited IE-AR-000012406

Similar devices in this category

Other devices filed under ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES.

Other devices from Apple Inc.

See all devices from Apple Inc. →

Properties

  • Measuring function
  • Over-the-counter
  • Lot / batch number
Other properties (22, all answered No)