https://wiki.teltonika-telemedic.com/index.php?action=history&feed=atom&title=UK_MHRA
UK MHRA - Revision history
2026-07-08T00:11:57Z
Revision history for this page on the wiki
MediaWiki 1.43.5
https://wiki.teltonika-telemedic.com/index.php?title=UK_MHRA&diff=1472&oldid=prev
Simonas.S: Protected "UK MHRA" ([Edit=Allow only administrators] (indefinite) [Move=Allow only administrators] (indefinite))
2026-06-25T11:59:40Z
<p>Protected "<a href="/view/UK_MHRA" title="UK MHRA">UK MHRA</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;">Revision as of 14:59, 25 June 2026</td>
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Simonas.S
https://wiki.teltonika-telemedic.com/index.php?title=UK_MHRA&diff=1455&oldid=prev
Simonas.S at 09:15, 25 June 2026
2026-06-25T09:15:14Z
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<td colspan="2" style="background-color: #fff; color: #202122; text-align: center;">Revision as of 12:15, 25 June 2026</td>
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<tr><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: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div><td style="vertical-align: middle; padding-right: <del style="font-weight: bold; text-decoration: none;">20px</del>; width: <del style="font-weight: bold; text-decoration: none;">96px</del>; background: #ffffff; border-radius: 8px;">[[File:MHRA-logo.png|center|frameless|<del style="font-weight: bold; text-decoration: none;">400x400px</del>]]</td><td style="vertical-align: left;"></div></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><td style="vertical-align: middle; padding-right: <ins style="font-weight: bold; text-decoration: none;">24px</ins>; width: <ins style="font-weight: bold; text-decoration: none;">240px</ins>; background: #ffffff; border-radius: 8px<ins style="font-weight: bold; text-decoration: none;">; padding: 14px 16px</ins>;">[[File:MHRA-logo.png<ins style="font-weight: bold; text-decoration: none;">|alt=MHRA logo.</ins>|center|frameless|<ins style="font-weight: bold; text-decoration: none;">220px</ins>]]</td><td style="vertical-align: left;"></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;">UK MHRA</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;">UK MHRA</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 with the Medicines and Healthcare products Regulatory Agency (MHRA) indicates compliance with the UK Medical Devices Regulations 2002, the regulatory framework governing medical devices placed on the market in the United Kingdom.</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 with the Medicines and Healthcare products Regulatory Agency (MHRA) indicates compliance with the UK Medical Devices Regulations 2002, the regulatory framework governing medical devices placed on the market in the United Kingdom.</div></div></td></tr>
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<tr><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: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div> </div></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;"><!-- External Links --></ins></div></td></tr>
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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;"><div style="padding:9px 12px; border-radius:7px; font-size:13px; font-weight:500; color:#374151; background:#f9fafb; border:1px solid #e5e7eb;">[https://pard.mhra.gov.uk/manufacturer-details/123217 🏥 Public Access Registration Database (PARD) →]</div></ins></div></td></tr>
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Simonas.S
https://wiki.teltonika-telemedic.com/index.php?title=UK_MHRA&diff=1454&oldid=prev
Simonas.S at 09:10, 25 June 2026
2026-06-25T09:10:54Z
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<td colspan="2" style="background-color: #fff; color: #202122; text-align: center;">Revision as of 12:10, 25 June 2026</td>
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<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><tr></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><tr></div></td></tr>
<tr><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: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div><td style="vertical-align: middle; padding-right: 20px; width: 96px; background: #ffffff; border-radius: 8px;">[[File:MHRA-logo.png<del style="font-weight: bold; text-decoration: none;">|alt=MHRA logo.</del>|center|frameless|<del style="font-weight: bold; text-decoration: none;">100x100px</del>]]</td><td style="vertical-align: left;"></div></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><td style="vertical-align: middle; padding-right: 20px; width: 96px; background: #ffffff; border-radius: 8px;">[[File:MHRA-logo.png|center|frameless|<ins style="font-weight: bold; text-decoration: none;">400x400px</ins>]]</td><td style="vertical-align: left;"></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;">UK MHRA</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;">UK MHRA</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 with the Medicines and Healthcare products Regulatory Agency (MHRA) indicates compliance with the UK Medical Devices Regulations 2002, the regulatory framework governing medical devices placed on the market in the United Kingdom.</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 with the Medicines and Healthcare products Regulatory Agency (MHRA) indicates compliance with the UK Medical Devices Regulations 2002, the regulatory framework governing medical devices placed on the market in the United Kingdom.</div></div></td></tr>
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Simonas.S
https://wiki.teltonika-telemedic.com/index.php?title=UK_MHRA&diff=1452&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);"> <table style="width: 100%; border-collapse: collapse;"> <tr> <td style="vertical-align: middle; p..."
2026-06-25T09:09:39Z
<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);"> <table style="width: 100%; border-collapse: collapse;"> <tr> <td style="vertical-align: middle; p..."</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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<td style="vertical-align: middle; padding-right: 20px; width: 96px; background: #ffffff; border-radius: 8px;">[[File:MHRA-logo.png|alt=MHRA logo.|center|frameless|100x100px]]</td><td style="vertical-align: left;"><br />
<div style="font-size: 28px; font-weight: 700; color: #ffffff; letter-spacing: -0.5px; margin-bottom: 8px;">UK MHRA</div><br />
<div style="color: #c4c4c4; font-size: 15px; line-height: 1.6;">Registration with the Medicines and Healthcare products Regulatory Agency (MHRA) indicates compliance with the UK Medical Devices Regulations 2002, the regulatory framework governing medical devices placed on the market in the United Kingdom.</div><br />
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<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #718096; margin-bottom: 16px;">📋 Regulatory Details</div><br />
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<div style="font-size: 15px; font-weight: 700; color: #2d3748;">TeltoHeart</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;">Trade Name</div><br />
<div style="font-size: 15px; font-weight: 700; color: #2d3748;">TeltoHeart</div><br />
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<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;">Physiologic Monitor / Medical Device Software</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;">GMDN Code</div><br />
<div style="font-size: 15px; font-weight: 700; color: #2d3748; font-family: 'Courier New', monospace;">66625</div><br />
<div style="font-size: 12px; color: #718096; margin-top: 4px;">Physiologic Monitor – Installed Software</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;">UK Medical Device Classification</div><br />
<div style="display:inline-block; background: #fffaf0; color: #c05621; font-size: 13px; font-weight: 700; padding: 4px 14px; border-radius: 20px;">Class IIb</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;">Applicable Regulation</div><br />
<div style="font-size: 15px; font-weight: 700; color: #2d3748;">UK Medical Devices Regulations 2002</div><br />
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<!-- Declaration --><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;">📄 Declaration of Conformity</div><br />
<div style="background: #ebf8ff; border: 1px solid #bee3f8; border-left: 4px solid #3182ce; border-radius: 8px; padding: 16px 20px; font-size: 14px; color: #2c5282; line-height: 1.7;">We, UAB Teltonika Telemedic, being the manufacturer of the above-mentioned medical device, declare under our sole responsibility that the device complies with the applicable requirements of the UK Medical Devices Regulations 2002.</div><br />
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<!-- MHRA 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: 16px;">🇬🇧 MHRA Registration Information</div><br />
<div style="font-size: 14px; color: #2d3748; line-height: 1.7; margin-bottom: 16px;">The device is registered with the Medicines and Healthcare products Regulatory Agency (MHRA):</div><br />
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<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;">MHRA Reference Number</div><br />
<div style="font-size: 15px; font-weight: 700; color: #2d3748; font-family: 'Courier New', monospace;">33173</div><br />
</td><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;">Date Registered</div><br />
<div style="font-size: 15px; font-weight: 700; color: #2d3748;">23/10/2024</div><br />
</td><br />
</tr><br />
<tr><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;">Manufacturer</div><br />
<div style="font-size: 15px; font-weight: 700; color: #2d3748;">UAB Teltonika Telemedic</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;">Manufacturer Address</div><br />
<div style="font-size: 15px; font-weight: 700; color: #2d3748;">Ukmergės g. 120-1, Vilnius, Lithuania LT-08126</div><br />
</td><br />
</tr><br />
<tr><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;">Customer Service Email</div><br />
<div style="font-size: 15px; font-weight: 700; color: #a0aec0;">Not Available</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;">Customer Service Telephone Number</div><br />
<div style="font-size: 15px; font-weight: 700; color: #a0aec0;">Not Available</div><br />
</td><br />
</tr><br />
<tr><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;">UK Responsible Person / NI Authorised Representative</div><br />
<div style="font-size: 15px; font-weight: 700; color: #2d3748;">Teltonika United Kingdom Ltd</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;">Relationship</div><br />
<div style="font-size: 15px; font-weight: 700; color: #2d3748;">UK Responsible Person</div><br />
</td><br />
</tr><br />
<tr><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;">Representative Address</div><br />
<div style="font-size: 15px; font-weight: 700; color: #2d3748;">Suite G1, Building 8 Quay Exchange, Salford, England, United Kingdom M5 3EJ</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 Brand / Trade Name</div><br />
<div style="font-size: 15px; font-weight: 700; color: #2d3748;">TeltoHeart</div><br />
</td><br />
</tr><br />
<tr><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;">GMDN® Code</div><br />
<div style="font-size: 15px; font-weight: 700; color: #2d3748; font-family: 'Courier New', monospace;">66625</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 Registration Status</div><br />
<div style="display:inline-block; background: #f0fff4; color: #276749; font-size: 13px; font-weight: 700; padding: 4px 14px; border-radius: 20px;">Registered</div><br />
</td><br />
</tr><br />
<tr><br />
<td colspan="2" 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;">Medical Device Risk Classification</div><br />
<div style="display:inline-block; background: #fffaf0; color: #c05621; font-size: 13px; font-weight: 700; padding: 4px 14px; border-radius: 20px;">Class IIb</div><br />
</td><br />
</tr><br />
</table><br />
</div><br />
<br />
</div></div>
Simonas.S