Myant Europe - Compliance & Legal

Regulatory overview

Legal Manufacturer under MDR: be-on-market GmbH, Lilienstrasse 33, D-91244
Reichenschwand, Germany
Swiss Authorised Representative under SwissMedic: Beyond Conception GmbH, Roosstrasse 53, 8832 Wollerau, Switzerland
Brand Owner and Technology Provider: Myant Health Inc, 2660 Speakman Dr, Mississauga, ON L5K 2L1, Canada
European Distributor: Myant Europe AG, Hofwisenstrasse 50A, 8153 Rümlang, Switzerland

Device family description

The SKIIN hardware and software is a group of CE-marked devices designed for remote ECG monitoring in ambulatory and home environments. It consists of:

1. SKIIN™ Garment

Type: Non-active, non-invasive medical device (ECG electrode garment)

Class: I

Purpose: A wearable chest band integrating textile-based ECG electrodes for continuous or periodic surface ECG acquisition. The garment transmits analog signals to the Skiin Pod for digitization and BLE transmission to the MHDS platform.

Indications: Ambulatory ECG monitoring in adults (≥18 years) with known or suspected arrhythmias, postoperative follow-up, or evaluation of palpitations, dizziness, chest pain, or dyspnea.

Contraindications:

- Use in or near patients with pacemakers, ICDs, or magnetically sensitive implants

- Implanted metallic medical devices

- MRI environments

- During external defibrillation

- Known allergies to textiles or conductive fibers

- Open or infected skin

- Pediatric or pregnant patients

Basic UDI-DI: 426067671_SKIIN_GARN_7R

Linked doc:

Operation and Safety Manual

2. SKIIN™ Pod

Type: Active, non-invasive data acquisition module

Class: I

Purpose: Digitizes and transmits ECG signals from the garment to the Myant Health Digital System (MHDS).

Indications: Remote, continuous ECG monitoring in adult patients (≥18 years) under clinical supervision.

Contraindications:

- MRI use

- Pacemakers or magnetically sensitive implants

- Pediatric or pregnant populations

UDI-DI: 628341952668

Linked doc:
Operation and Safety Manual

3. Myant Health Digital System (MHDS)

Type: Software as a Medical Device (SaMD)
Class: 2a
Purpose: Securely receives, stores, displays, and manages ECG data acquired via the SKIIN™ Pod and SKIIN™ Garment; clinicians review and manage monitoring sessions in MVCP; no automated diagnostic conclusions.

Indications: Supports remote ambulatory ECG monitoring when used with SKIIN™ Pod and Skiin Garment for adult patients (18+).

Intended Users: MVCP—healthcare professionals (and authorized admin staff for non-medical tasks); SCLA-A—patients; MBE—no direct user interface.

Contraindications:
No software-specific contraindications

Components & UDI-DI: SCLA-A (Skiin Connected Life Heartbeat) 628341958240; MVCP (Myant Virtual Clinic Portal) 628341955034; MBE (Myant Back End) 628341958257

Linked doc:

Instructions for use (eIFU)