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TeltoHeart Certification & Approvals: Difference between revisions

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<div style="background: linear-gradient(135deg, #1a202c 0%, #2d3748 60%, #1a365d 100%); border-radius: 12px; padding: 36px 40px; margin-bottom: 24px;">
<div style="background: linear-gradient(135deg, #1a202c 0%, #2d3748 60%, #1a365d 100%); border-radius: 12px; padding: 36px 40px; margin-bottom: 24px;">
<div style="font-size: 28px; font-weight: 700; color: #ffffff; letter-spacing: -0.5px; margin-bottom: 8px;">Certifications, Approvals &amp; Declarations</div>
<div style="font-size: 28px; font-weight: 700; color: #ffffff; letter-spacing: -0.5px; margin-bottom: 8px;">Certifications, Approvals &amp; Declarations</div>
<div style="color: #c4c4c4; font-size: 15px; line-height: 1.6; max-width: 720px;">Here information about TeltoHeart Certification, Approvals &amp; Declarations can be found.</div>
<div style="color: #c4c4c4; font-size: 15px; line-height: 1.6; max-width: 720px;">Here information about Certification, Approvals &amp; Declarations can be found.</div>
</div>
</div>
<!-- Color legend -->
<table style="width: 100%; border-collapse: collapse; margin-bottom: 24px;">
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<td style="background: #ebf8ff; border-bottom: 3px solid #3182ce; padding: 10px 14px; width: 25%;">
<span style="font-size: 12px; font-weight: 600; color: #2c5282;">Radio &amp; EMC</span>
</td>
<td style="background: #fff5f5; border-bottom: 3px solid #e53e3e; padding: 10px 14px; width: 25%;">
<span style="font-size: 12px; font-weight: 600; color: #9b2c2c;">Medical device</span>
</td>
<td style="background: #f0fff4; border-bottom: 3px solid #38a169; padding: 10px 14px; width: 25%;">
<span style="font-size: 12px; font-weight: 600; color: #276749;">Environmental &amp; chemical</span>
</td>
<td style="background: #fffbeb; border-bottom: 3px solid #d97706; padding: 10px 14px; width: 25%;">
<span style="font-size: 12px; font-weight: 600; color: #975a16;">National marks</span>
</td>
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<td style="width: 33%; background: #f7f7f5; border-radius: 8px; padding: 16px;">
<td style="width: 33%; background: #f7f7f5; border-radius: 8px; padding: 16px;">
<div style="font-size: 13px; color: #718096; margin-bottom: 4px;">Certifications</div>
<div style="font-size: 13px; color: #718096; margin-bottom: 4px;">Certifications</div>
<div style="font-size: 24px; font-weight: 600; color: #2d3748;">9</div>
<div style="font-size: 24px; font-weight: 600; color: #2d3748;">13</div>
</td>
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<td style="width: 33%; background: #f7f7f5; border-radius: 8px; padding: 16px;">
<td style="width: 33%; background: #f7f7f5; border-radius: 8px; padding: 16px;">
<div style="font-size: 13px; color: #718096; margin-bottom: 4px;">Regions</div>
<div style="font-size: 13px; color: #718096; margin-bottom: 4px;">Regions</div>
<div style="font-size: 24px; font-weight: 600; color: #2d3748;">5</div>
<div style="font-size: 24px; font-weight: 600; color: #2d3748;">7</div>
</td>
</td>
<td style="width: 33%; background: #f7f7f5; border-radius: 8px; padding: 16px;">
<td style="width: 33%; background: #f7f7f5; border-radius: 8px; padding: 16px;">
<div style="font-size: 13px; color: #718096; margin-bottom: 4px;">Categories</div>
<div style="font-size: 13px; color: #718096; margin-bottom: 4px;">Categories</div>
<div style="font-size: 24px; font-weight: 600; color: #2d3748;">4</div>
<div style="font-size: 24px; font-weight: 600; color: #2d3748;">3</div>
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<span style="font-size: 13px; font-weight: 600; color: #718096;">Radio &amp; EMC compliance</span>
<span style="font-size: 13px; font-weight: 600; color: #718096;">Radio &amp; EMC compliance</span>
</div>
</div>
<table style="width: 100%; border-collapse: separate; border-spacing: 8px 0; margin-bottom: 24px;">
<table style="width: 100%; border-collapse: separate; border-spacing: 8px 0; margin-bottom: 8px;">
<tr>
<tr>
<td style="width: 33%; background: #ebf8ff; border: 1px solid #bee3f8; border-radius: 8px; padding: 14px 16px; vertical-align: top;">
<td style="width: 33%; background: #ebf8ff; border: 1px solid #bee3f8; border-radius: 8px; padding: 14px 16px; vertical-align: top;">
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<span style="background: #ffffff; color: #718096; font-size: 11px; font-weight: 600; padding: 3px 8px; border-radius: 6px; border: 1px solid #e2e8f0;">US</span>
<span style="background: #ffffff; color: #718096; font-size: 11px; font-weight: 600; padding: 3px 8px; border-radius: 6px; border: 1px solid #e2e8f0;">US</span>
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<table style="width: 100%; border-collapse: separate; border-spacing: 8px 0; margin-bottom: 24px;">
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<td style="width: 33%; background: #ebf8ff; border: 1px solid #bee3f8; border-radius: 8px; padding: 14px 16px; vertical-align: top;">
<table style="width: 100%; border-collapse: collapse; margin-bottom: 6px;">
<tr>
<td style="width: 36px; vertical-align: middle; padding-right: 10px;">
<div style="background: #ffffff; border: 1px solid #bee3f8; border-radius: 6px; width: 36px; height: 36px; text-align: center; padding: 4px 0;">[[File:ISED logo.png|alt=ISED logo.|center|frameless|208px]]</div>
</td>
<td style="vertical-align: middle;">
<div style="font-size: 14px; font-weight: 600; color: #2c5282;">[[TeltoHeart IC | ISED]]</div>
</td>
</tr>
</table>
<div style="font-size: 12px; color: #4a5568; margin: 2px 0 8px;">Innovation, Science and Economic Development Canada</div>
<span style="background: #ffffff; color: #718096; font-size: 11px; font-weight: 600; padding: 3px 8px; border-radius: 6px; border: 1px solid #e2e8f0;">CA</span>
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<td style="width: 33%;"></td>
<td style="width: 33%;"></td>
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<span style="font-size: 13px; font-weight: 600; color: #718096;">Medical device regulation</span>
<span style="font-size: 13px; font-weight: 600; color: #718096;">Medical device regulation</span>
</div>
</div>
<table style="width: 100%; border-collapse: separate; border-spacing: 8px 0; margin-bottom: 24px;">
<table style="width: 100%; border-collapse: separate; border-spacing: 8px 0; margin-bottom: 8px;">
<tr>
<tr>
<td style="width: 33%; background: #fff5f5; border: 1px solid #fed7d7; border-radius: 8px; padding: 14px 16px; vertical-align: top;">
<td style="width: 33%; background: #fff5f5; border: 1px solid #fed7d7; border-radius: 8px; padding: 14px 16px; vertical-align: top;">
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<span style="background: #ffffff; color: #718096; font-size: 11px; font-weight: 600; padding: 3px 8px; border-radius: 6px; border: 1px solid #e2e8f0;">EU</span>
<span style="background: #ffffff; color: #718096; font-size: 11px; font-weight: 600; padding: 3px 8px; border-radius: 6px; border: 1px solid #e2e8f0;">EU</span>
</td>
</td>
<td style="width: 33%;"></td>
<td style="width: 33%; background: #fff5f5; border: 1px solid #fed7d7; border-radius: 8px; padding: 14px 16px; vertical-align: top;">
<td style="width: 33%;"></td>
<table style="width: 100%; border-collapse: collapse; margin-bottom: 6px;">
<tr>
<td style="width: 36px; vertical-align: middle; padding-right: 10px;">
<div style="background: #ffffff; border: 1px solid #fed7d7; border-radius: 6px; width: 36px; height: 36px; text-align: center; padding: 4px 0;">[[File:MHRA-logo.png|alt=MHRA logo.|center|frameless|32px]]</div>
</td>
<td style="vertical-align: middle;">
<div style="font-size: 14px; font-weight: 600; color: #9b2c2c;">[[UK_MHRA | UK MHRA]]</div>
</td>
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<div style="font-size: 12px; color: #4a5568; margin: 2px 0 8px;">Medical Devices Regulations 2002</div>
<span style="background: #ffffff; color: #718096; font-size: 11px; font-weight: 600; padding: 3px 8px; border-radius: 6px; border: 1px solid #e2e8f0;">UK</span>
</td>
<td style="width: 33%; background: #fff5f5; border: 1px solid #fed7d7; border-radius: 8px; padding: 14px 16px; vertical-align: top;">
<table style="width: 100%; border-collapse: collapse; margin-bottom: 6px;">
<tr>
<td style="width: 36px; vertical-align: middle; padding-right: 10px;">
<div style="background: #ffffff; border: 1px solid #fed7d7; border-radius: 6px; width: 36px; height: 36px; text-align: center; padding: 4px 0;">[[File:Kenya_PPB_logo.png|alt=Kenya Pharmacy and Poisons Board logo.|center|frameless|28px]]</div>
</td>
<td style="vertical-align: middle;">
<div style="font-size: 14px; font-weight: 600; color: #9b2c2c;">[[TeltoHeart_PPB | PPB]]</div>
</td>
</tr>
</table>
<div style="font-size: 12px; color: #4a5568; margin: 2px 0 8px;">Pharmacy and Poisons Board</div>
<span style="background: #ffffff; color: #718096; font-size: 11px; font-weight: 600; padding: 3px 8px; border-radius: 6px; border: 1px solid #e2e8f0;">KE</span>
</td>
</tr>
</table>
<table style="width: 100%; border-collapse: separate; border-spacing: 8px 0; margin-bottom: 24px;">
<tr>
<td style="width: 33%; background: #fff5f5; border: 1px solid #fed7d7; border-radius: 8px; padding: 14px 16px; vertical-align: top;">
<table style="width: 100%; border-collapse: collapse; margin-bottom: 6px;">
<tr>
<td style="width: 36px; vertical-align: middle; padding-right: 10px;">
<div style="background: #ffffff; border: 1px solid #fed7d7; border-radius: 6px; width: 36px; height: 36px; text-align: center; padding: 4px 0;">[[File:Kazakhstan_MOH_logo.png|alt=Kazakhstan Ministry of Healthcare logo.|center|frameless|28px]]</div>
</td>
<td style="vertical-align: middle;">
<div style="font-size: 14px; font-weight: 600; color: #9b2c2c;">[[TeltoHeart_KZ | Kazakhstan registration]]</div>
</td>
</tr>
</table>
<div style="font-size: 12px; color: #4a5568; margin: 2px 0 8px;">Ministry of Healthcare registration</div>
<span style="background: #ffffff; color: #718096; font-size: 11px; font-weight: 600; padding: 3px 8px; border-radius: 6px; border: 1px solid #e2e8f0;">KZ</span>
</td>
<td style="width: 33%; background: #fff5f5; border: 1px solid #fed7d7; border-radius: 8px; padding: 14px 16px; vertical-align: top;">
<table style="width: 100%; border-collapse: collapse; margin-bottom: 6px;">
<tr>
<td style="width: 36px; vertical-align: middle; padding-right: 10px;">
<div style="background: #ffffff; border: 1px solid #fed7d7; border-radius: 6px; width: 36px; height: 36px; text-align: center; padding: 4px 0;">[[File:Italy_MOH_logo.png|alt=Italian Ministry of Health logo.|center|frameless|28px]]</div>
</td>
<td style="vertical-align: middle;">
<div style="font-size: 14px; font-weight: 600; color: #9b2c2c;">[[IT_MOH | IT MOH]]</div>
</td>
</tr>
</table>
<div style="font-size: 12px; color: #4a5568; margin: 2px 0 8px;">BD/RDM Registration</div>
<span style="background: #ffffff; color: #718096; font-size: 11px; font-weight: 600; padding: 3px 8px; border-radius: 6px; border: 1px solid #e2e8f0;">IT</span>
</td>
<td style="width: 33%; background: #fff5f5; border: 1px solid #fed7d7; border-radius: 8px; padding: 14px 16px; vertical-align: top;">
<table style="width: 100%; border-collapse: collapse; margin-bottom: 6px;">
<tr>
<td style="width: 36px; vertical-align: middle; padding-right: 10px;">
<div style="background: #ffffff; border: 1px solid #fed7d7; border-radius: 6px; width: 36px; height: 36px; text-align: center; padding: 4px 0;">[[File:Eudamed.png|alt=EUDAMED logo.|center|frameless|28px]]</div>
</td>
<td style="vertical-align: middle;">
<div style="font-size: 14px; font-weight: 600; color: #9b2c2c;">[[EUDAMED | EUDAMED]]</div>
</td>
</tr>
</table>
<div style="font-size: 12px; color: #4a5568; margin: 2px 0 8px;">European Database on Medical Devices</div>
<span style="background: #ffffff; color: #718096; font-size: 11px; font-weight: 600; padding: 3px 8px; border-radius: 6px; border: 1px solid #e2e8f0;">EU</span>
</td>
</tr>
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</table>
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<span style="font-size: 13px; font-weight: 600; color: #718096;">Environmental &amp; chemical compliance</span>
<span style="font-size: 13px; font-weight: 600; color: #718096;">Environmental &amp; chemical compliance</span>
</div>
</div>
<table style="width: 100%; border-collapse: separate; border-spacing: 8px 0; margin-bottom: 24px;">
<table style="width: 100%; border-collapse: separate; border-spacing: 8px 0;">
<tr>
<tr>
<td style="width: 33%; background: #f0fff4; border: 1px solid #c6f6d5; border-radius: 8px; padding: 14px 16px; vertical-align: top;">
<td style="width: 33%; background: #f0fff4; border: 1px solid #c6f6d5; border-radius: 8px; padding: 14px 16px; vertical-align: top;">
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</td>
</td>
<td style="width: 33%; background: #f0fff4; border: 1px solid #c6f6d5; border-radius: 8px; padding: 14px 16px; vertical-align: top;">
<td style="width: 33%; background: #f0fff4; border: 1px solid #c6f6d5; border-radius: 8px; padding: 14px 16px; vertical-align: top;">
<table style="width: 100%; border-collapse: collapse; margin-bottom: 6px;">
<tr>
<td style="width: 36px; vertical-align: middle; padding-right: 10px;">
<div style="background: #ffffff; border: 1px solid #c6f6d5; border-radius: 6px; width: 36px; height: 36px; text-align: center; padding: 4px 0; font-size:20px; line-height:26px;">📄</div>
</td>
<td style="vertical-align: middle;">
<div style="font-size: 14px; font-weight: 600; color: #276749;">[[TeltoHeart_REACH | REACH]]</div>
<div style="font-size: 14px; font-weight: 600; color: #276749;">[[TeltoHeart_REACH | REACH]]</div>
</td>
</tr>
</table>
<div style="font-size: 12px; color: #4a5568; margin: 2px 0 8px;">Registration, Evaluation, Authorisation and Restriction of Chemicals</div>
<div style="font-size: 12px; color: #4a5568; margin: 2px 0 8px;">Registration, Evaluation, Authorisation and Restriction of Chemicals</div>
<span style="background: #ffffff; color: #718096; font-size: 11px; font-weight: 600; padding: 3px 8px; border-radius: 6px; border: 1px solid #e2e8f0;">EU</span>
<span style="background: #ffffff; color: #718096; font-size: 11px; font-weight: 600; padding: 3px 8px; border-radius: 6px; border: 1px solid #e2e8f0;">EU</span>
</td>
</td>
<td style="width: 33%; background: #f0fff4; border: 1px solid #c6f6d5; border-radius: 8px; padding: 14px 16px; vertical-align: top;">
<td style="width: 33%; background: #f0fff4; border: 1px solid #c6f6d5; border-radius: 8px; padding: 14px 16px; vertical-align: top;">
<table style="width: 100%; border-collapse: collapse; margin-bottom: 6px;">
<tr>
<td style="width: 36px; vertical-align: middle; padding-right: 10px;">
<div style="background: #ffffff; border: 1px solid #c6f6d5; border-radius: 6px; width: 36px; height: 36px; text-align: center; padding: 4px 0; font-size:20px; line-height:26px;">📄</div>
</td>
<td style="vertical-align: middle;">
<div style="font-size: 14px; font-weight: 600; color: #276749;">[[TeltoHeart_Regulation (EU) 2023/1542 | Batteries Regulation]]</div>
<div style="font-size: 14px; font-weight: 600; color: #276749;">[[TeltoHeart_Regulation (EU) 2023/1542 | Batteries Regulation]]</div>
<div style="font-size: 12px; color: #4a5568; margin: 2px 0 8px;">Regulation (EU) 2023/1542</div>
<span style="background: #ffffff; color: #718096; font-size: 11px; font-weight: 600; padding: 3px 8px; border-radius: 6px; border: 1px solid #e2e8f0;">EU</span>
</td>
</td>
</tr>
</tr>
</table>
</table>
 
<div style="font-size: 12px; color: #4a5568; margin: 2px 0 8px;">Regulation (EU) 2023/1542</div>
<!-- Category: National conformity marks -->
<span style="background: #ffffff; color: #718096; font-size: 11px; font-weight: 600; padding: 3px 8px; border-radius: 6px; border: 1px solid #e2e8f0;">EU</span>
<div style="display: flex; align-items: center; gap: 8px; margin: 0 0 10px;">
<span style="width: 8px; height: 8px; border-radius: 50%; background: #d97706; display: inline-block;"></span>
<span style="font-size: 13px; font-weight: 600; color: #718096;">National conformity marks</span>
</div>
<table style="width: 100%; border-collapse: separate; border-spacing: 8px 0;">
<tr>
<td style="width: 33%; background: #fffbeb; border: 1px solid #fbd38d; border-radius: 8px; padding: 14px 16px; vertical-align: top;">
<div style="font-size: 14px; font-weight: 600; color: #975a16;">[[TeltoHeart_PPB | PPB]]</div>
<div style="font-size: 12px; color: #4a5568; margin: 2px 0 8px;">Kenya Bureau of Standards</div>
<span style="background: #ffffff; color: #718096; font-size: 11px; font-weight: 600; padding: 3px 8px; border-radius: 6px; border: 1px solid #e2e8f0;">KE</span>
</td>
</td>
<td style="width: 33%; background: #fffbeb; border: 1px solid #fbd38d; border-radius: 8px; padding: 14px 16px; vertical-align: top;">
<div style="font-size: 14px; font-weight: 600; color: #975a16;">[[TeltoHeart_KZ | Kazakhstan mark]]</div>
<div style="font-size: 12px; color: #4a5568; margin: 2px 0 8px;">Conformity mark</div>
<span style="background: #ffffff; color: #718096; font-size: 11px; font-weight: 600; padding: 3px 8px; border-radius: 6px; border: 1px solid #e2e8f0;">KZ</span>
</td>
<td style="width: 33%;"></td>
</tr>
</tr>
</table>
</table>


</div>
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Latest revision as of 09:53, 9 July 2026

Certifications, Approvals & Declarations
Here information about Certification, Approvals & Declarations can be found.
Certifications
13
Regions
7
Categories
3

Radio & EMC compliance

CE logo.
Radio Equipment Directive

EU

UKCA logo.
UK Conformity Assessment

UK

FCC logo.
Federal Communications Commission

US

ISED logo.
Innovation, Science and Economic Development Canada

CA

Medical device regulation

CE MDR logo.
Medical Device Regulation

EU

MHRA logo.
Medical Devices Regulations 2002

UK

Kenya Pharmacy and Poisons Board logo.
Pharmacy and Poisons Board

KE

Kazakhstan Ministry of Healthcare logo.
Ministry of Healthcare registration

KZ

Italian Ministry of Health logo.
BD/RDM Registration

IT

EUDAMED logo.
European Database on Medical Devices

EU

Environmental & chemical compliance

RoHS logo.
Restriction of Hazardous Substances

EU

📄
Registration, Evaluation, Authorisation and Restriction of Chemicals

EU

📄
Regulation (EU) 2023/1542

EU

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