EUDAMED
Main Page > TeltoHeart > EUDAMED
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EUDAMED
European Database on Medical Devices — registration details for MyHealth App & TeltoHeart
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MyHealth App — Medical Device Software
📋 Regulatory Details
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Product Software Name
MyHealth App
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Single Registration Number (SRN)
LT-MF-000007642
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Product Classification
Class IIa
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EC Certificate Number
MDR-009
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Notified Body Number
1304
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Notified Body Name
SIQ Ljubljana
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🏷️ UDI Identifiers
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Basic UDI-DI / EUDAMED DI
477905185MHAppQH
Issuing Agency: GS1 |
(Master) UDI-DI / EUDAMED ID
04779051850174
Issuing Agency: GS1 |
🗂️ Additional Details
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Manufacturer
Teltonika Telemedic UAB
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Legislation
MDR (EU) 2017/745
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First on Market
Lithuania
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Reference
MH001
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🧩 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:
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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
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Product Name
TeltoHeart
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Product Classification
Class I
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Classification Rule
Rule 13
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Conformity Route
Self-declared (Class I — no Notified Body)
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Applicable Regulation
MDR (Regulation (EU) 2017/745)
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Active Device
Yes
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🏷️ UDI Identifiers
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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.