Organization name

Apple Inc.

SRN

US-MF-000013709

Manufacturer status

Active

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

• CW011

  The feature cannot detect a heart attack. If you ever experience chest pain, pressure, tightness or what you think is a heart attack, call emergency services immediately.
• CW999

  The feature cannot identify every instance of hypertension. Regular blood pressure screenings are the most effective way to look for hypertension. The feature cannot detect other conditions such as blood clots, stroke, atrial fibrillation, congestive heart failure or high cholesterol. The feature should not be turned on during pregnancy. The feature cannot detect pre-eclampsia or other hypertensive conditions related to pregnancy. If you are not feeling well, you should talk to your doctor.

Primary placement in Ireland; 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.

00195949001796

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.

0195949HTNF2

Reference / catalog number

Hypertension Notification Feature 1.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 Hypertension Notification Feature (HTNF) is a software-only mobile medical application that analyzes photoplethysmography (PPG) data opportunistically collected by Apple Watch to identify patterns that are suggestive of hypertension and provides a notification to the user. The feature is intended for over-the-counter (OTC) use by adults age 22 and over who have not been previously diagnosed with hypertension. It is not intended to replace traditional methods of diagnosis, to monitor hypertension treatment effect, or to be used as a method of blood pressure surveillance. It is not intended for use during pregnancy. The absence of a notification does not indicate the absence of hypertension. Target Population and Intended Users The Hypertension Notification Feature is indicated for adults aged 22 and older who have not previously received a hypertension diagnosis. The feature is not intended for use during pregnancy.

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.

• Z12039092VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS - MEDICAL DEVICE SOFTWARE

• Class IIa medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.