Lumen Devices·Regulatory

Regulatory Information

Last updated: October 2026

This page describes the regulatory status of the medical devices Lumen Wellness Devices supplies. The information has been compiled in good faith from manufacturer documentation. Specific device classifications, certificate numbers, and manufacturer details should be verified against the supplied Instructions for Use (IFU) for each device, which prevail in case of any inconsistency.

Our role

Lumen Wellness Devices is a supplier and distributor of CE-marked medical devices to clinicians and medical practices in Ireland and the United Kingdom. We are not the legal manufacturer of any of the devices we supply. The legal manufacturer is responsible for product design, conformity assessment, post-market surveillance, and regulatory compliance under the EU Medical Devices Regulation (Regulation (EU) 2017/745, "MDR") and the UK Medical Devices Regulations 2002 as amended.

Our responsibilities as a distributor include verifying that devices we supply bear a valid CE mark, ensuring devices reach our customers in the condition supplied to us by the manufacturer, providing access to manufacturer Instructions for Use, and cooperating with the manufacturer and competent authorities in respect of post-market vigilance.

Devices we supply

Eko Health

CORE 500™ Digital Stethoscope

A digital stethoscope with active noise reduction, audio amplification, integrated 3-lead ECG capture, and an on-device display.

Manufacturer
Eko Devices, Inc., United States
Regulatory status
CE marked under the EU Medical Devices Regulation (MDR). UKCA / UK MHRA registered.
Intended use
Auscultation of heart, lung, and other body sounds by trained clinicians, with optional digital amplification, recording, and AI-assisted decision support where applicable.
VentriJect

Seismofit® VO₂max System

A non-invasive seismocardiography device that estimates cardiorespiratory fitness (VO₂max) at rest, in under three minutes, using a small chest-mounted sensor.

Manufacturer
VentriJect ApS, Denmark
Regulatory status
CE marked, Class I medical device under the EU Medical Devices Regulation (MDR).
Intended use
Estimation of cardiorespiratory fitness (VO₂max) in adult patients at rest, for use by qualified clinicians as an indicator of cardiovascular health and longevity risk.
Manufacturer information
ventriject.com

Instructions for Use

Each device we supply is accompanied by manufacturer-provided Instructions for Use (IFU), which describe intended use, indications, contraindications, performance characteristics, training requirements, and safety information. Clinicians using a device must read and follow the IFU. Replacement copies of any IFU are available on request from info@lumenwellness.ie.

Vigilance and adverse event reporting

If you experience or become aware of an adverse event, near miss, or device malfunction involving a product supplied by Lumen Wellness Devices, please notify us as soon as practicable so that we can support reporting to the manufacturer and to the relevant competent authority.

Vigilance contact

Lumen Wellness Devices
Email: info@lumenwellness.ie
Subject line: Vigilance Report

In Ireland, serious adverse incidents involving medical devices may also be reported directly to the Health Products Regulatory Authority (HPRA):

Competent authority — Ireland

Health Products Regulatory Authority (HPRA)
Kevin O'Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2
Web: www.hpra.ie

Veterinary use

The CE marking described above relates to each device's intended use in human patients, and the ECG and AI-assisted features of the Eko platform are validated in humans. EU medical device regulation does not extend to veterinary use. Where we supply the CORE 500 to veterinary practices, it is supplied as an auscultation instrument for use at the veterinarian's professional discretion. Eko Vet+ (canine murmur detection) is a separate Eko product and is not yet available in Ireland.

Important notice on intended use

The devices we supply are intended for use by qualified clinicians. They are diagnostic and decision-support tools and are not a substitute for clinical judgement. AI features in any device or platform are intended to support clinicians, not to replace clinical assessment. Patients are not expected to interpret raw output from these devices on their own.