Organization name

Apple Inc.

SRN

US-MF-000013709

Manufacturer status

Active

4 warnings recorded — scroll inside the panel to see all entries.

• Caution

  The ECG app cannot check for signs of a heart attack. If you believe you’re having a medical emergency, call emergency services.

• DO NOT use to diagnose heart-related conditions.

  OTHER

• DO NOT change your medication without talking to your doctor.

  OTHER

• Not intended for use by individuals under the age of 22.

  OTHER

Primary placement in Germany; available across 32 countries total.

Trade name

not provided

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

00190199649286

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

0190199ECGApp2QP

Reference / catalog number

ECG app 2.X

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The ECG app is a software-only mobile medical application intended for use with the Apple Watch to create, record, store, transfer, and display a single channel electrocardiogram (ECG) similar to a Lead I ECG. The ECG app determines the presence of atrial fibrillation (AFib), sinus rhythm, and high heart rate (no AF detected with heart rate 100-150 bpm) on a classifiable waveform. The ECG app is not recommended for users with other known arrhythmias. The ECG app is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG app is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from sinus rhythm and is not intended to replace traditional methods of diagnosis or treatment. The ECG app is not intended for use by people under 22 years old.

Additional information URL

https://regulatoryinfo.apple.com/ifu/ecg

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z12050382ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES

• Class IIa medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.

Certificate health across this manufacturer's portfolio.