EUDAMED device

Irregular Rhythm Notification Feature

EUDAMED device 00190198909527 · Apple Inc.

Key facts

Primary DI 00190198909527
Device name Irregular Rhythm Notification Feature
Reference or catalog number 1.X
Model 1.X
Manufacturer Apple Inc.
Manufacturer SRN US-MF-000013709
Risk class Class IIa
EMDN code Z12039092
EMDN description VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS - MEDICAL DEVICE SOFTWARE
Legislation mdr
Implantable No
Sterile No
Single use No
Status date Aug 26, 2025

At a glance

  • Yes Matching FDA GUDID record

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About EUDAMED devices

EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.

Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date:

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