EUDAMED

EUDAMED European Database on Medical Devices — registration details for MyHealth App & TeltoHeart

MyHealth App — Medical Device Software

📋 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.

TeltoHeart — Accessory Medical Device

📋 Regulatory Details

Product Name TeltoHeart	Product Classification Class I
Classification Rule Rule 13	Conformity Route Self-declared (Class I — no Notified Body)
Applicable Regulation MDR (Regulation (EU) 2017/745)	Active Device Yes

🏷️ UDI Identifiers

Basic UDI-DI / EUDAMED DI 4779051850TeltoHeartHD Issuing Agency: GS1

📄 Intended Use

TeltoHeart is an accessory medical device that functions solely as a physiological data acquisition and transmission instrument. It collects raw PPG signal (from which heart rate is extrapolated), raw ECG data via physical electrodes, and transmits this data to the platform (MyHealth app software). TeltoHeart does not perform any algorithmic analysis or generate any clinical outputs.

All data analysis, including detection of suspected atrial fibrillation via the PPG-based AF algorithm, is performed exclusively within the MyHealth app software. If atrial fibrillation is suspected, the MyHealth app software generates a notification which is relayed to the patient via the TeltoHeart device. This notification indicates a suspicion only and does not constitute a diagnosis.

Manually recorded ECG data can be forwarded by the patient to their medical practitioner for further interpretation. The diagnosis is determined solely by a qualified medical practitioner.