Skip to content

Irregular Rhythm Notifications Feature Version 1.x

by Apple Inc.

Ref Irregular Rhythm Notification Feature 1.XModel 1.X

Irregular Rhythm Notifications Feature Version 1.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 26 Aug 2025 (Basic UDI-DI 0190198IRNFeature3T), granted FDA De Novo DEN180042 and listed in FDA GUDID since 14 Jan 2019 (UDI-DI 00190198909510), active as of 23 Oct 2026.

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

CE MDR De Novo

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

De Novo DEN180042↗

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0190198IRNFeature3T Basic UDI-DI 00190198909510UDI-DIDate26 Aug 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00190198909510 UDI-DI Date14 Jan 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA De Novo GUDID from GUDID NumberDEN180042 Date—StatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0190198IRNFeature3T registered 26 Aug 2025 Active
  • FDA De Novo DEN180042 Active
  • FDA GUDID UDI-DI 00190198909510 listed 14 Jan 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00190198909510
  2. Registered EUDAMED 0190198IRNFeature3T

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA De Novo Active

Specification

EUDAMED · GUDID

Trade name
Irregular Rhythm Notifications
Generic name
Self-care monitoring/reporting software
Device name
Irregular Rhythm Notification Feature
Model / reference
1.X EUDAMED
Irregular Rhythm Notification Feature 1.X EUDAMED
Feature Version 1.x GUDID
Primary DI / UDI-DI
00190198909510
Basic UDI-DI
0190198IRNFeature3T
Direct marketing DI
00190198909510
De Novo Number
FDA product code
QDB
EMDN code
Z12039092 Various instruments to support and monitor vital signs - medical device software
GMDN term
Self-care monitoring/reporting software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.2790
Special device type
Software
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
1.X
Irregular Rhythm Notification Feature 1.X
GUDID
Feature Version 1.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.

Related devices

Category: Self-care monitoring/reporting software

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS - MEDICAL DEVICE SOFTWARE.

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)