https://wiki.teltonika-telemedic.com/index.php?action=history&feed=atom&title=IT_MOH
IT MOH - Revision history
2026-07-08T00:27:43Z
Revision history for this page on the wiki
MediaWiki 1.43.5
https://wiki.teltonika-telemedic.com/index.php?title=IT_MOH&diff=1497&oldid=prev
Simonas.S at 10:46, 7 July 2026
2026-07-07T10:46:14Z
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<td colspan="2" style="background-color: #fff; color: #202122; text-align: center;">Revision as of 13:46, 7 July 2026</td>
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<tr><td colspan="2" class="diff-side-deleted"></td><td class="diff-marker" data-marker="+"></td><td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div><ins style="font-weight: bold; text-decoration: none;"><td style="vertical-align: middle; padding-left: 12px;"></ins></div></td></tr>
<tr><td class="diff-marker"></td><td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div><div style="font-size: 28px; font-weight: 700; color: #ffffff; letter-spacing: -0.5px; margin-bottom: 8px;">Italy MOH — BD/RDM Registration</div></div></td><td class="diff-marker"></td><td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div><div style="font-size: 28px; font-weight: 700; color: #ffffff; letter-spacing: -0.5px; margin-bottom: 8px;">Italy MOH — BD/RDM Registration</div></div></td></tr>
<tr><td class="diff-marker"></td><td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><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></div></td><td class="diff-marker"></td><td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><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></div></td></tr>
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Simonas.S
https://wiki.teltonika-telemedic.com/index.php?title=IT_MOH&diff=1470&oldid=prev
Simonas.S: Protected "IT MOH" ([Edit=Allow only administrators] (indefinite) [Move=Allow only administrators] (indefinite))
2026-06-25T11:59:23Z
<p>Protected "<a href="/view/IT_MOH" title="IT MOH">IT MOH</a>" ([Edit=Allow only administrators] (indefinite) [Move=Allow only administrators] (indefinite))</p>
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<td colspan="2" style="background-color: #fff; color: #202122; text-align: center;">← Older revision</td>
<td colspan="2" style="background-color: #fff; color: #202122; text-align: center;">Revision as of 14:59, 25 June 2026</td>
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Simonas.S
https://wiki.teltonika-telemedic.com/index.php?title=IT_MOH&diff=1458&oldid=prev
Simonas.S: Created page with "Category:TeltoHeart <div style="font-family: -apple-system, BlinkMacSystemFont, 'Segoe UI', Roboto, sans-serif; max-width: 960px; margin: 0 auto; padding: 16px;"> <!-- Header --> <div style="background: linear-gradient(135deg, #1a1a1a 0%, #2d2d2d 50%, #3a3a3a 100%); border-radius: 12px; padding: 36px 40px; margin-bottom: 28px; box-shadow: 0 4px 24px rgba(0,0,0,0.18);"> <div style="font-size: 28px; font-weight: 700; color: #ffffff; letter-spacing: -0.5px; margin-bot..."
2026-06-25T09:37:03Z
<p>Created page with "<a href="/view/Category:TeltoHeart" title="Category:TeltoHeart">Category:TeltoHeart</a> <div style="font-family: -apple-system, BlinkMacSystemFont, 'Segoe UI', Roboto, sans-serif; max-width: 960px; margin: 0 auto; padding: 16px;"> <!-- Header --> <div style="background: linear-gradient(135deg, #1a1a1a 0%, #2d2d2d 50%, #3a3a3a 100%); border-radius: 12px; padding: 36px 40px; margin-bottom: 28px; box-shadow: 0 4px 24px rgba(0,0,0,0.18);"> <div style="font-size: 28px; font-weight: 700; color: #ffffff; letter-spacing: -0.5px; margin-bot..."</p>
<p><b>New page</b></p><div>[[Category:TeltoHeart]]<br />
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<div style="font-family: -apple-system, BlinkMacSystemFont, 'Segoe UI', Roboto, sans-serif; max-width: 960px; margin: 0 auto; padding: 16px;"><br />
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<div style="background: linear-gradient(135deg, #1a1a1a 0%, #2d2d2d 50%, #3a3a3a 100%); border-radius: 12px; padding: 36px 40px; margin-bottom: 28px; box-shadow: 0 4px 24px rgba(0,0,0,0.18);"><br />
<div style="font-size: 28px; font-weight: 700; color: #ffffff; letter-spacing: -0.5px; margin-bottom: 8px;">Italy MOH — BD/RDM Registration</div><br />
<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><br />
</div><br />
<br />
<!-- Manufacturer & Device --><br />
<div style="background: #ffffff; border: 1px solid #e2e8f0; border-radius: 10px; padding: 28px 32px; margin-bottom: 28px;"><br />
<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #718096; margin-bottom: 16px;">Manufacturer &amp; Medical Device</div><br />
<table style="width: 100%; border-collapse: separate; border-spacing: 10px;"><br />
<tr><br />
<td style="width: 50%; background: #f7fafc; border: 1px solid #e2e8f0; border-radius: 8px; padding: 14px 18px; vertical-align: top;"><br />
<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #a0aec0; margin-bottom: 6px;">Manufacturer</div><br />
<div style="font-size: 15px; font-weight: 700; color: #2d3748;">Teltonika Telemedic UAB</div><br />
<div style="font-size: 12px; color: #718096; margin-top: 4px;">Ukmergės g. 120-1, Vilnius, Lithuania</div><br />
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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><br />
<div style="font-size: 15px; font-weight: 700; color: #2d3748; font-family: 'Courier New', monospace;">LT-MF-000007642</div><br />
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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><br />
<div style="font-size: 15px; font-weight: 700; color: #2d3748;">MyHealth App</div><br />
</td><br />
<td style="background: #f7fafc; border: 1px solid #e2e8f0; border-radius: 8px; padding: 14px 18px; vertical-align: top;"><br />
<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #a0aec0; margin-bottom: 6px;">Trade Name</div><br />
<div style="font-size: 15px; font-weight: 700; color: #2d3748;">MYHEALTH APP</div><br />
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</tr><br />
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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><br />
<div style="font-size: 15px; font-weight: 700; color: #2d3748; font-family: 'Courier New', monospace;">MH001</div><br />
</td><br />
<td style="background: #f7fafc; border: 1px solid #e2e8f0; border-radius: 8px; padding: 14px 18px; vertical-align: top;"><br />
<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #a0aec0; margin-bottom: 6px;">Device Type</div><br />
<div style="font-size: 15px; font-weight: 700; color: #2d3748;">Medical Device Software</div><br />
</td><br />
</tr><br />
</table><br />
</div><br />
<br />
<!-- Classification & Applicable Regulation --><br />
<div style="background: #ffffff; border: 1px solid #e2e8f0; border-radius: 10px; padding: 28px 32px; margin-bottom: 28px;"><br />
<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #718096; margin-bottom: 14px;">Classification &amp; Applicable Regulation</div><br />
<br />
<table style="width: 100%; border-collapse: collapse; margin-bottom: 8px;"><br />
<tr><td style="padding: 0 0 8px 0;"><br />
<table style="width: 100%; background: #f7fafc; border: 1px solid #e2e8f0; border-left: 4px solid #3182ce; border-radius: 8px; border-collapse: collapse;"><br />
<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><br />
</table><br />
</td></tr><br />
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<table style="width: 100%; background: #f7fafc; border: 1px solid #e2e8f0; border-left: 4px solid #3182ce; border-radius: 8px; border-collapse: collapse;"><br />
<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><br />
</table><br />
</td></tr><br />
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</div><br />
<br />
<!-- Declaration --><br />
<div style="background: #ebf8ff; border: 1px solid #bee3f8; border-left: 4px solid #3182ce; border-radius: 8px; padding: 16px 20px; margin-bottom: 28px; font-size: 14px; color: #2c5282; line-height: 1.7;"><br />
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.<br />
</div><br />
<br />
<!-- Registration Information --><br />
<div style="background: #ffffff; border: 1px solid #e2e8f0; border-radius: 10px; padding: 28px 32px; margin-bottom: 28px;"><br />
<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #718096; margin-bottom: 14px;">Registration Information</div><br />
<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><br />
<br />
<table style="width: 100%; border-collapse: collapse; border-radius: 8px; overflow: hidden; border: 1px solid #e2e8f0;"><br />
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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><br />
<td style="padding: 12px 16px; font-size: 12px; font-weight: 700; text-transform: uppercase; letter-spacing: 0.5px; color: #ffffff;">Details</td><br />
</tr><br />
<tr style="background: #f7fafc; border-top: 1px solid #e2e8f0;"><br />
<td style="padding: 14px 16px; font-size: 13px; color: #2d3748; font-weight: 600;">BD/RDM Registration Identifier</td><br />
<td style="padding: 14px 16px; font-size: 13px; color: #2d3748; font-family: 'Courier New', monospace;">2676270</td><br />
</tr><br />
<tr style="background: #ffffff; border-top: 1px solid #e2e8f0;"><br />
<td style="padding: 14px 16px; font-size: 13px; color: #2d3748; font-weight: 600;">Registered in the Repertory</td><br />
<td style="padding: 14px 16px; font-size: 13px; color: #2d3748;">Yes</td><br />
</tr><br />
<tr style="background: #f7fafc; border-top: 1px solid #e2e8f0;"><br />
<td style="padding: 14px 16px; font-size: 13px; color: #2d3748; font-weight: 600;">Code Assigned by Manufacturer / Assembler</td><br />
<td style="padding: 14px 16px; font-size: 13px; color: #2d3748; font-family: 'Courier New', monospace;">MH001</td><br />
</tr><br />
<tr style="background: #ffffff; border-top: 1px solid #e2e8f0;"><br />
<td style="padding: 14px 16px; font-size: 13px; color: #2d3748; font-weight: 600;">Trade Name / Model</td><br />
<td style="padding: 14px 16px; font-size: 13px; color: #2d3748;">MYHEALTH APP</td><br />
</tr><br />
<tr style="background: #f7fafc; border-top: 1px solid #e2e8f0;"><br />
<td style="padding: 14px 16px; font-size: 13px; color: #2d3748; font-weight: 600;">National Classification of Medical Devices (CND)</td><br />
<td style="padding: 14px 16px; font-size: 13px; color: #2d3748;">Z12030692 – Telemetry equipment for vital parameters – Medical device software</td><br />
</tr><br />
<tr style="background: #ffffff; border-top: 1px solid #e2e8f0;"><br />
<td style="padding: 14px 16px; font-size: 13px; color: #2d3748; font-weight: 600;">Regulation / Legislation</td><br />
<td style="padding: 14px 16px; font-size: 13px; color: #2d3748;">Regulation (EU) 2017/745 (Medical Device Regulation – MDR)</td><br />
</tr><br />
<tr style="background: #f7fafc; border-top: 1px solid #e2e8f0;"><br />
<td style="padding: 14px 16px; font-size: 13px; color: #2d3748; font-weight: 600;">CLASSE CE</td><br />
<td style="padding: 14px 16px; font-size: 13px; color: #2d3748;">R2A - CLASSE IIA</td><br />
</tr><br />
<tr style="background: #ffffff; border-top: 1px solid #e2e8f0;"><br />
<td style="padding: 14px 16px; font-size: 13px; color: #2d3748; font-weight: 600;">Date of First Publication</td><br />
<td style="padding: 14px 16px; font-size: 13px; color: #2d3748;">15/10/2024</td><br />
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<tr style="background: #f7fafc; border-top: 1px solid #e2e8f0;"><br />
<td style="padding: 14px 16px; font-size: 13px; color: #2d3748; font-weight: 600;">Company Role</td><br />
<td style="padding: 14px 16px; font-size: 13px; color: #2d3748;">Manufacturer</td><br />
</tr><br />
<tr style="background: #ffffff; border-top: 1px solid #e2e8f0;"><br />
<td style="padding: 14px 16px; font-size: 13px; color: #2d3748; font-weight: 600;">Manufacturer Name</td><br />
<td style="padding: 14px 16px; font-size: 13px; color: #2d3748;">TELTONIKA TELEMEDIC UAB</td><br />
</tr><br />
<tr style="background: #f7fafc; border-top: 1px solid #e2e8f0;"><br />
<td style="padding: 14px 16px; font-size: 13px; color: #2d3748; font-weight: 600;">VAT Number</td><br />
<td style="padding: 14px 16px; font-size: 13px; color: #2d3748; font-family: 'Courier New', monospace;">100013091815</td><br />
</tr><br />
<tr style="background: #ffffff; border-top: 1px solid #e2e8f0;"><br />
<td style="padding: 14px 16px; font-size: 13px; color: #2d3748; font-weight: 600;">Country</td><br />
<td style="padding: 14px 16px; font-size: 13px; color: #2d3748;">Lithuania</td><br />
</tr><br />
</table><br />
</div><br />
<br />
<!-- External Links --><br />
<div style="background: #ffffff; border: 1px solid #e2e8f0; border-radius: 10px; padding: 20px 28px;"><br />
<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #718096; margin-bottom: 12px;">External Links</div><br />
<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><br />
</div><br />
<br />
</div><br />
[[Category:TeltoHeart Certification & Approvals]]</div>
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