View source for EUDAMED

[[Category:TeltoHeart]]
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<div style="font-size: 28px; font-weight: 700; color: #ffffff; letter-spacing: -0.5px; margin-bottom: 8px;">EUDAMED</div>
<div style="color: #c4c4c4; font-size: 15px; line-height: 1.6;">European Database on Medical Devices — registration details for MyHealth App</div>
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<div style="font-size: 15px; font-weight: 700; color: #2d3748;">MyHealth App</div>
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<div style="font-size: 15px; font-weight: 700; color: #2d3748; font-family: 'Courier New', monospace;">1304</div>
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<div style="font-size: 15px; font-weight: 700; color: #2d3748;">SIQ Ljubljana</div>
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<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #276749; margin-bottom: 6px;">Basic UDI-DI / EUDAMED DI</div>
<div style="font-size: 16px; font-weight: 700; color: #1a202c; font-family: 'Courier New', monospace; letter-spacing: 0.5px; margin-bottom: 8px;">477905185MHAppQH</div>
<span style="display:inline-block; background: #ffffff; color: #276749; font-size: 11px; font-weight: 700; padding: 3px 10px; border-radius: 6px; border: 1px solid #c6f6d5;">Issuing Agency: GS1</span>
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<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #276749; margin-bottom: 6px;">(Master) UDI-DI / EUDAMED ID</div>
<div style="font-size: 16px; font-weight: 700; color: #1a202c; font-family: 'Courier New', monospace; letter-spacing: 0.5px; margin-bottom: 8px;">04779051850174</div>
<span style="display:inline-block; background: #ffffff; color: #276749; font-size: 11px; font-weight: 700; padding: 3px 10px; border-radius: 6px; border: 1px solid #c6f6d5;">Issuing Agency: GS1</span>
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<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #a0aec0; margin-bottom: 6px;">Manufacturer</div>
<div style="font-size: 15px; font-weight: 700; color: #2d3748;">Teltonika Telemedic UAB</div>
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<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #a0aec0; margin-bottom: 6px;">Legislation</div>
<div style="font-size: 15px; font-weight: 700; color: #2d3748;">MDR (EU) 2017/745</div>
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<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #a0aec0; margin-bottom: 6px;">First on Market</div>
<div style="font-size: 15px; font-weight: 700; color: #2d3748;">Lithuania</div>
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<div style="font-size: 15px; font-weight: 700; color: #2d3748; font-family: 'Courier New', monospace;">MH001</div>
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<div style="font-size: 15px; font-weight: 700; color: #1a202c; font-family: 'Courier New', monospace; margin-bottom: 6px;">Z12039092</div>
<div style="font-size: 14px; color: #4a5568; line-height: 1.5;">Various instruments to support and monitor vital signs — Medical Device Software</div>
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<!-- Description -->
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<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #718096; margin-bottom: 14px;">📄 Intended use</div>
<div style="font-size: 14px; color: #2d3748; line-height: 1.7; margin-bottom: 16px;">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:</div>
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<tr><td style="padding: 12px 16px; font-size: 14px; color: #2d3748; line-height: 1.6;">Automatic recording of heart rate data extrapolated from PPG signal</td></tr>
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<tr><td style="padding: 12px 16px; font-size: 14px; color: #2d3748; line-height: 1.6;">Detection of suspected atrial fibrillation from PPG-based AF algorithm</td></tr>
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<div style="font-size: 14px; color: #2d3748; line-height: 1.7; margin-bottom: 12px;">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.</div>
<div style="font-size: 14px; color: #2d3748; line-height: 1.7; margin-bottom: 12px;">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.</div>
<div style="background: #ebf8ff; border: 1px solid #bee3f8; border-left: 4px solid #3182ce; border-radius: 8px; padding: 12px 16px; font-size: 14px; color: #2c5282; line-height: 1.6;">MyHealth app and TeltoHeart are intended for use by adults aged 22 and above.</div>
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