View source for IT MOH

[[Category:TeltoHeart]]

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<td style="vertical-align: middle; padding-right: 20px; width: 96px; background: #ffffff; border-radius: 8px;"><div style="text-align: center; padding-left: 6px;">[[File:Italy_MOH_logo.png|alt=UKCA logo.|center|frameless|80x80px]]</div></td>
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<div style="font-size: 28px; font-weight: 700; color: #ffffff; letter-spacing: -0.5px; margin-bottom: 8px;">Italy MOH — BD/RDM Registration</div>
<div style="color: #c4c4c4; font-size: 15px; line-height: 1.6;">Registration in the Italian Ministry of Health's Banca Dati / Repertorio Dispositivi Medici (BD/RDM) is required for medical devices placed on the Italian market under Regulation (EU) 2017/745 (MDR).</div>
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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>
<div style="font-size: 12px; color: #718096; margin-top: 4px;">Ukmergės g. 120-1, Vilnius, Lithuania</div>
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<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #a0aec0; margin-bottom: 6px;">Single Registration Number (SRN)</div>
<div style="font-size: 15px; font-weight: 700; color: #2d3748; font-family: 'Courier New', monospace;">LT-MF-000007642</div>
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<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #a0aec0; margin-bottom: 6px;">Device Name</div>
<div style="font-size: 15px; font-weight: 700; color: #2d3748;">MyHealth App</div>
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<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #a0aec0; margin-bottom: 6px;">Trade Name</div>
<div style="font-size: 15px; font-weight: 700; color: #2d3748;">MYHEALTH APP</div>
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<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #a0aec0; margin-bottom: 6px;">Manufacturer Code</div>
<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: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #a0aec0; margin-bottom: 6px;">Device Type</div>
<div style="font-size: 15px; font-weight: 700; color: #2d3748;">Medical Device Software</div>
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<tr><td style="padding: 12px 16px; font-size: 14px; color: #2d3748; line-height: 1.6;">The device is classified as <strong>Class IIa medical device</strong> according to Regulation (EU) 2017/745 (MDR) on medical devices.</td></tr>
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<tr><td style="padding: 12px 16px; font-size: 14px; color: #2d3748; line-height: 1.6;">This Declaration of Conformity is issued under Regulation (EU) 2017/745 of the European Parliament and of the Council.</td></tr>
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We, Teltonika Telemedic UAB, being the manufacturer of the above-mentioned medical device, declare under our sole responsibility that the device complies with the applicable requirements of Regulation (EU) 2017/745. The device has been assessed according to the applicable conformity assessment procedure and is eligible to bear the CE marking.
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<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #718096; margin-bottom: 14px;">Registration Information</div>
<div style="font-size: 14px; color: #2d3748; line-height: 1.7; margin-bottom: 16px;">The device is registered in the Italian Ministry of Health Medical Device Database (BD/RDM):</div>

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<td style="padding: 12px 16px; font-size: 12px; font-weight: 700; text-transform: uppercase; letter-spacing: 0.5px; color: #ffffff; width: 45%;">Field</td>
<td style="padding: 12px 16px; font-size: 12px; font-weight: 700; text-transform: uppercase; letter-spacing: 0.5px; color: #ffffff;">Details</td>
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<td style="padding: 14px 16px; font-size: 13px; color: #2d3748; font-weight: 600;">BD/RDM Registration Identifier</td>
<td style="padding: 14px 16px; font-size: 13px; color: #2d3748; font-family: 'Courier New', monospace;">2676270</td>
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<td style="padding: 14px 16px; font-size: 13px; color: #2d3748; font-weight: 600;">Registered in the Repertory</td>
<td style="padding: 14px 16px; font-size: 13px; color: #2d3748;">Yes</td>
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<td style="padding: 14px 16px; font-size: 13px; color: #2d3748; font-weight: 600;">Code Assigned by Manufacturer / Assembler</td>
<td style="padding: 14px 16px; font-size: 13px; color: #2d3748; font-family: 'Courier New', monospace;">MH001</td>
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<td style="padding: 14px 16px; font-size: 13px; color: #2d3748; font-weight: 600;">Trade Name / Model</td>
<td style="padding: 14px 16px; font-size: 13px; color: #2d3748;">MYHEALTH APP</td>
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<td style="padding: 14px 16px; font-size: 13px; color: #2d3748; font-weight: 600;">National Classification of Medical Devices (CND)</td>
<td style="padding: 14px 16px; font-size: 13px; color: #2d3748;">Z12030692 – Telemetry equipment for vital parameters – Medical device software</td>
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<td style="padding: 14px 16px; font-size: 13px; color: #2d3748; font-weight: 600;">Regulation / Legislation</td>
<td style="padding: 14px 16px; font-size: 13px; color: #2d3748;">Regulation (EU) 2017/745 (Medical Device Regulation – MDR)</td>
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<td style="padding: 14px 16px; font-size: 13px; color: #2d3748; font-weight: 600;">CLASSE CE</td>
<td style="padding: 14px 16px; font-size: 13px; color: #2d3748;">R2A - CLASSE IIA</td>
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<td style="padding: 14px 16px; font-size: 13px; color: #2d3748; font-weight: 600;">Date of First Publication</td>
<td style="padding: 14px 16px; font-size: 13px; color: #2d3748;">15/10/2024</td>
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<td style="padding: 14px 16px; font-size: 13px; color: #2d3748; font-weight: 600;">Company Role</td>
<td style="padding: 14px 16px; font-size: 13px; color: #2d3748;">Manufacturer</td>
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<td style="padding: 14px 16px; font-size: 13px; color: #2d3748; font-weight: 600;">Manufacturer Name</td>
<td style="padding: 14px 16px; font-size: 13px; color: #2d3748;">TELTONIKA TELEMEDIC UAB</td>
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<td style="padding: 14px 16px; font-size: 13px; color: #2d3748; font-weight: 600;">VAT Number</td>
<td style="padding: 14px 16px; font-size: 13px; color: #2d3748; font-family: 'Courier New', monospace;">100013091815</td>
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<td style="padding: 14px 16px; font-size: 13px; color: #2d3748; font-weight: 600;">Country</td>
<td style="padding: 14px 16px; font-size: 13px; color: #2d3748;">Lithuania</td>
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<div style="padding:9px 12px; border-radius:7px; font-size:13px; font-weight:500; color:#374151; background:#f9fafb; border:1px solid #e5e7eb;">[https://www.salute.gov.it/new/it/tema/dispositivi-medici/registrazione-dei-dispositivi-medici-nella-banca-dati-nazionale/ 🏥 Ministero della Salute &mdash; BD/RDM Registration of Medical Devices →]</div>
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[[Category:TeltoHeart Certification & Approvals]]