TeltoHeart Certification & Approvals: Difference between revisions

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Certifications, Approvals & Declarations

Here information about Certification, Approvals & Declarations can be found.

Certifications

13

Regions

7

Categories

3

Radio & EMC compliance

CE RED

Radio Equipment Directive

EU

UKCA

UK Conformity Assessment

UK

FCC

Federal Communications Commission

US

ISED

Innovation, Science and Economic Development Canada

CA

Medical device regulation

CE MDR

Medical Device Regulation

EU

UK MHRA

Medical Devices Regulations 2002

UK

PPB

Pharmacy and Poisons Board

KE

Kazakhstan registration

Ministry of Healthcare registration

KZ

IT MOH

BD/RDM Registration

IT

EUDAMED

European Database on Medical Devices

EU

Environmental & chemical compliance

RoHS

Restriction of Hazardous Substances

EU

📄

REACH

Registration, Evaluation, Authorisation and Restriction of Chemicals

EU

📄	Batteries Regulation

Regulation (EU) 2023/1542

EU

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 <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: 24px; font-weight: 600; color: #2d3748;">12</div>
+<div style="font-size: 24px; font-weight: 600; color: #2d3748;">13</div>
 </td>
 <td style="width: 33%; background: #f7f7f5; border-radius: 8px; padding: 16px;">
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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;">IT</span>
 </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;">
+<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>
 </table>
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 </td>
 <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>
+</td>
+</tr>
+</table>
 <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>
 </td>
 <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>
+</td>
+</tr>
+</table>
 <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>