EUDAMED

European Database on Medical Devices — registration details for MyHealth App

📋 Regulatory Details

Product Software Name MyHealth App	Single Registration Number (SRN) LT-MF-000007642
Product Classification Class IIa	EC Certificate Number MDR-009
Notified Body Number 1304	Notified Body Name SIQ Ljubljana

🏷️ UDI Identifiers

Basic UDI-DI / EUDAMED DI

477905185MHAppQH

Issuing Agency: GS1

(Master) UDI-DI / EUDAMED ID

04779051850174

Issuing Agency: GS1

🗂️ Additional Details

Manufacturer Teltonika Telemedic UAB	Legislation MDR (EU) 2017/745	First on Market Lithuania
Reference MH001

🧩 EMDN Classification

Z12039092

Various instruments to support and monitor vital signs — Medical Device Software

📄 Intended use

This medical device, MyHealth app together with accessory medical device TeltoHeart, is intended to be used for patient heart monitoring in hospital and home environments. Heart monitoring functionality consists of:

Automatic recording of heart rate data extrapolated from PPG signal

Detection of suspected atrial fibrillation from PPG-based AF algorithm

Manual 6-lead ECG recording using physical electrodes

Heart rate and rhythm data is interpreted by an algorithm in the MyHealth app, which detects atrial fibrillation and alerts the patient if any are detected by way of notifications on the accessory device TeltoHeart. Electrocardiogram (ECG) is recorded manually on the TeltoHeart device by the patient and can be sent to their medical practitioner (e.g., cardiologist or other qualified medical staff) for further interpretation and help in diagnosis.

The device does not diagnose any medical conditions. For more precise diagnosis, it is recommended to use standalone electrocardiographs or use smart wearable data only in conjunction with additional medical examination data. The diagnosis is determined only by a medical practitioner.

MyHealth app and TeltoHeart are intended for use by adults aged 22 and above.