Skip to content

Irregular Rhythm Notification Feature

by Apple Inc. 2 variants

Ref 2.X

Irregular Rhythm Notification Feature (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 26 Aug 2025 (Basic UDI-DI 0194252IRNFeature22Q), cleared under FDA 510(k) K212516 on 22 Oct 2021 and granted FDA De Novo DEN180042 on 11 Sep 2018 and in 1 more registry, active as of 24 Oct 2026.

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

CE MDR 510(k) De Novo

Valid until

No date given

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

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K212516

+1 more

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0194252IRNFeature22Q Basic UDI-DI 00194252456781UDI-DIDate26 Aug 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00194252456781 UDI-DI Date14 Mar 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK212516 Date22 Oct 2021DecidedStatusActive
United StatesFDA De Novo De Novo NumberDEN180042 Date11 Sep 2018IssuedStatusActive

Official records

Across registries

4 registries list this device

  • EUDAMED Basic UDI-DI 0194252IRNFeature22Q registered 26 Aug 2025 Active
  • FDA 510(k) K212516 decided 22 Oct 2021 Active
  • FDA De Novo DEN180042 decided 11 Sep 2018 Active
  • FDA GUDID UDI-DI 00194252456781 listed 14 Mar 2022 Listed

Timeline

4 dated events

  1. Granted FDA De Novo DEN180042
  2. Cleared FDA 510(k) K212516
  3. Listed FDA GUDID 00194252456781
  4. Registered EUDAMED 0194252IRNFeature22Q

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade name
Irregular Rhythm Notification feature 2.0
Generic name
Self-care monitoring/reporting software
Model / reference
2.X EUDAMED
Feature Version 2.x GUDID
Primary DI / UDI-DI
00194252456781
Basic UDI-DI
0194252IRNFeature22Q
Direct marketing DI
00194252456781
510(k) 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
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
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 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)