View source for UK MHRA

[[Category:TeltoHeart]]

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<td style="vertical-align: middle; padding-right: 24px; width: 240px; background: #ffffff; border-radius: 8px; padding: 14px 16px;">[[File:MHRA-logo.png|alt=MHRA logo.|center|frameless|220px]]</td><td style="vertical-align: left;">
<div style="font-size: 28px; font-weight: 700; color: #ffffff; letter-spacing: -0.5px; margin-bottom: 8px;">UK MHRA</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>
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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>
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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;">TeltoHeart</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;">TeltoHeart</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;">Physiologic Monitor / Medical Device Software</div>
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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>
<div style="font-size: 15px; font-weight: 700; color: #2d3748; font-family: 'Courier New', monospace;">66625</div>
<div style="font-size: 12px; color: #718096; margin-top: 4px;">Physiologic Monitor – Installed Software</div>
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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>
<div style="display:inline-block; background: #fffaf0; color: #c05621; font-size: 13px; font-weight: 700; padding: 4px 14px; border-radius: 20px;">Class IIb</div>
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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>
<div style="font-size: 15px; font-weight: 700; color: #2d3748;">UK Medical Devices Regulations 2002</div>
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<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #718096; margin-bottom: 14px;">📄 Declaration of Conformity</div>
<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>
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<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #718096; margin-bottom: 16px;">🇬🇧 MHRA Registration Information</div>
<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>

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<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #a0aec0; margin-bottom: 6px;">MHRA Reference Number</div>
<div style="font-size: 15px; font-weight: 700; color: #2d3748; font-family: 'Courier New', monospace;">33173</div>
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<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #a0aec0; margin-bottom: 6px;">Date Registered</div>
<div style="font-size: 15px; font-weight: 700; color: #2d3748;">23/10/2024</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;">UAB Teltonika Telemedic</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 Address</div>
<div style="font-size: 15px; font-weight: 700; color: #2d3748;">Ukmergės g. 120-1, Vilnius, Lithuania LT-08126</div>
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<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #a0aec0; margin-bottom: 6px;">Customer Service Email</div>
<div style="font-size: 15px; font-weight: 700; color: #a0aec0;">Not Available</div>
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<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #a0aec0; margin-bottom: 6px;">Customer Service Telephone Number</div>
<div style="font-size: 15px; font-weight: 700; color: #a0aec0;">Not Available</div>
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<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>
<div style="font-size: 15px; font-weight: 700; color: #2d3748;">Teltonika United Kingdom Ltd</div>
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<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #a0aec0; margin-bottom: 6px;">Relationship</div>
<div style="font-size: 15px; font-weight: 700; color: #2d3748;">UK Responsible Person</div>
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<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #a0aec0; margin-bottom: 6px;">Representative Address</div>
<div style="font-size: 15px; font-weight: 700; color: #2d3748;">Suite G1, Building 8 Quay Exchange, Salford, England, United Kingdom M5 3EJ</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 Brand / Trade Name</div>
<div style="font-size: 15px; font-weight: 700; color: #2d3748;">TeltoHeart</div>
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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>
<div style="font-size: 15px; font-weight: 700; color: #2d3748; font-family: 'Courier New', monospace;">66625</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 Registration Status</div>
<div style="display:inline-block; background: #f0fff4; color: #276749; font-size: 13px; font-weight: 700; padding: 4px 14px; border-radius: 20px;">Registered</div>
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<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #a0aec0; margin-bottom: 6px;">Medical Device Risk Classification</div>
<div style="display:inline-block; background: #fffaf0; color: #c05621; font-size: 13px; font-weight: 700; padding: 4px 14px; border-radius: 20px;">Class IIb</div>
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<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #718096; margin-bottom: 12px;">External Links</div>
<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>
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