Organization name

Apple Inc.

SRN

US-MF-000013709

Manufacturer status

Active

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

• CW011

  Cycle Tracking is not indicated for contraceptive use.
• CW999

  DO NOT use the predicted fertile windows or ovulation estimates as a form of birth control. DO NOT use data from the Health app and Cycle Tracking to diagnose health conditions. DO NOT take clinical action including making changes to your medication without consultation with a qualified health care professional.

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.

00194253312512

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.

0194253CycleTracking44C

Reference / catalog number

Cycle Tracking App 4.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 I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Cycle Tracking is a software-only application intended to track and predict menstrual cycles, including ovulation, in order to inform users about their menstrual health and to facilitate conception (not to be used for contraception). Cycle Tracking analyzes user inputs including typical cycle length, typical period length, menstrual flow, and ovulation test results, along with aggregates of sedentary heart rate and wrist temperature.

Additional information URL

No additional information URL provided by the manufacturer.

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.

• Z12080282GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - SOFTWARE ACCESSORIES

• Class I medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.