PulseOn Arrhythmia Monitor System

Organization name

PulseOn Oy

SRN

FI-MF-000009325

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW011

  EUDAMED did not publish a description for this code.
• CW014

  EUDAMED did not publish a description for this code.

Primary placement in Finland; available across 32 countries total.

Trade name

PulseOn Arrhythmia Monitor System

UDI-DI code

06430054330206

Basic UDI-DI

643005433AMSD4

Reference / catalog number

AMS-1

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The PulseOn Arrhythmia Monitor System is used to assist in the diagnosis, screening and monitoring of atrial fibrillation and other cardiac arrhythmias visible in Lead I ECG. The system consists of a wrist-worn device and a data management service. The wrist device optically monitors pulse rate during periods of no motion, in order to detect possible atrial fibrillation, and it is used to take intermittent single-lead electrocardiogram (ECG) measurements between the arms. The wrist device stores the measured data, which is later transferred to the data management service where the data can be analysed by medical professionals. The device is intended to be used inside or outside a hospital environment. The usage period of the system can vary from days to several weeks.

Additional information URL

https://www.pulseon.com/

Clinical sizes

No clinical sizes registered for this device.

• C020599CARDIAC DIAGNOSTIC DEVICES - OTHER

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

This device is not currently linked to any other device.