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==TeltoHeart ECG200 – Regulatory and Registration Information==
[[Category:TeltoHeart]]


Manufacturer: UAB TELTONIKA TELEMEDIC, Lithuania
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Manufacturing Site: UAB TELTONIKA TELEMEDIC, Lithuania
Authorized Representative in Kazakhstan: ТОО TELTONIKA (Телтоника)


Device Name: TeltoHeart ECG200
<!-- Header -->
Device Type: Wearable medical device (ECG monitor)
<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);">
Risk Class: Class 2a – medium risk
<div style="font-size: 28px; font-weight: 700; color: #ffffff; letter-spacing: -0.5px; margin-bottom: 8px;">TeltoHeart ECG200 – Kazakhstan Registration</div>
<div style="color: #c4c4c4; font-size: 15px; line-height: 1.6;">Regulatory and registration information for the Republic of Kazakhstan.</div>
</div>


==Registration:==
<!-- Device Info -->
<div style="background: #ffffff; border: 1px solid #e2e8f0; border-radius: 10px; padding: 28px 32px; margin-bottom: 28px;">
<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #718096; margin-bottom: 16px;">Device Information</div>
<table style="width: 100%; border-collapse: collapse;">
<tr style="border-bottom: 1px solid #e2e8f0;">
<td style="padding: 10px 12px; font-size: 13px; font-weight: 600; color: #718096; width: 35%;">Manufacturer</td>
<td style="padding: 10px 12px; font-size: 14px; color: #2d3748;">UAB TELTONIKA TELEMEDIC, Lithuania</td>
</tr>
<tr style="border-bottom: 1px solid #e2e8f0; background: #f7fafc;">
<td style="padding: 10px 12px; font-size: 13px; font-weight: 600; color: #718096;">Manufacturing Site</td>
<td style="padding: 10px 12px; font-size: 14px; color: #2d3748;">UAB TELTONIKA TELEMEDIC, Lithuania</td>
</tr>
<tr style="border-bottom: 1px solid #e2e8f0;">
<td style="padding: 10px 12px; font-size: 13px; font-weight: 600; color: #718096;">Authorized Representative in Kazakhstan</td>
<td style="padding: 10px 12px; font-size: 14px; color: #2d3748;">ТОО TELTONIKA (Телтоника)</td>
</tr>
<tr style="border-bottom: 1px solid #e2e8f0; background: #f7fafc;">
<td style="padding: 10px 12px; font-size: 13px; font-weight: 600; color: #718096;">Device Name</td>
<td style="padding: 10px 12px; font-size: 14px; color: #2d3748;">TeltoHeart ECG200</td>
</tr>
<tr style="border-bottom: 1px solid #e2e8f0;">
<td style="padding: 10px 12px; font-size: 13px; font-weight: 600; color: #718096;">Device Type</td>
<td style="padding: 10px 12px; font-size: 14px; color: #2d3748;">Wearable medical device (ECG monitor)</td>
</tr>
<tr style="background: #f7fafc;">
<td style="padding: 10px 12px; font-size: 13px; font-weight: 600; color: #718096;">Risk Class</td>
<td style="padding: 10px 12px; font-size: 14px; color: #2d3748;"><span style="background: #ebf8ff; color: #2b6cb0; font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 0.5px; padding: 3px 10px; border-radius: 20px;">Class 2a – Medium Risk</span></td>
</tr>
</table>
</div>


Certificate Number: РК МИ (МТ)-0№028722
<!-- Registration -->
NICAD Number: KZ09VBP00026308
<div style="background: #ffffff; border: 1px solid #e2e8f0; border-radius: 10px; padding: 28px 32px; margin-bottom: 28px;">
Date of State Registration: 13 November 2024, №N081094
<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #718096; margin-bottom: 16px;">Registration</div>
Validity: Indefinite
<table style="width: 100%; border-collapse: collapse;">
Applicable Law: In accordance with the Code of the Republic of Kazakhstan “On the Health of the People and the Healthcare System” and the Law on Electronic Documents and Digital Signatures (7 January 2003), this certificate is legally equivalent to a paper document.
<tr style="border-bottom: 1px solid #e2e8f0;">
<td style="padding: 10px 12px; font-size: 13px; font-weight: 600; color: #718096; width: 35%;">Certificate Number</td>
<td style="padding: 10px 12px; font-size: 14px; color: #2d3748;">РК МИ (МТ)-0№028722</td>
</tr>
<tr style="border-bottom: 1px solid #e2e8f0; background: #f7fafc;">
<td style="padding: 10px 12px; font-size: 13px; font-weight: 600; color: #718096;">NICAD Number</td>
<td style="padding: 10px 12px; font-size: 14px; color: #2d3748;">KZ09VBP00026308</td>
</tr>
<tr style="border-bottom: 1px solid #e2e8f0;">
<td style="padding: 10px 12px; font-size: 13px; font-weight: 600; color: #718096;">Date of State Registration</td>
<td style="padding: 10px 12px; font-size: 14px; color: #2d3748;">13 November 2024, №N081094</td>
</tr>
<tr style="background: #f7fafc;">
<td style="padding: 10px 12px; font-size: 13px; font-weight: 600; color: #718096;">Validity</td>
<td style="padding: 10px 12px; font-size: 14px; color: #2d3748;"><span style="background: #f0fff4; color: #276749; font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 0.5px; padding: 3px 10px; border-radius: 20px;">Indefinite</span></td>
</tr>
</table>
<div style="margin-top: 16px; background: #ebf8ff; border: 1px solid #bee3f8; border-left: 4px solid #3182ce; border-radius: 8px; padding: 12px 16px; font-size: 13px; color: #2c5282; line-height: 1.6;">In accordance with the Code of the Republic of Kazakhstan "On the Health of the People and the Healthcare System" and the Law on Electronic Documents and Digital Signatures (7 January 2003), this certificate is legally equivalent to a paper document.</div>
</div>


==Scope of Use:==
<!-- Scope of Use -->
<div style="background: #ffffff; border: 1px solid #e2e8f0; border-radius: 10px; padding: 28px 32px; margin-bottom: 28px;">
<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #718096; margin-bottom: 14px;">Scope of Use</div>
<div style="font-size: 14px; color: #2d3748; line-height: 1.7; margin-bottom: 10px;">The TeltoHeart ECG200 is registered and approved for use in medical practice across the territory of the Republic of Kazakhstan.</div>
<div style="font-size: 14px; color: #2d3748; line-height: 1.7;">A list of consumables and components associated with the device is provided in the appendix to this registration certificate (Form 3, 1 sheet).</div>
</div>


The TeltoHeart ECG200 is registered and approved for use in medical practice across the territory of the Republic of Kazakhstan.
<!-- Regulatory Authority -->
A list of consumables and components associated with the device is provided in the appendix to this registration certificate (Form 3, 1 sheet).
<div style="background: #ffffff; border: 1px solid #e2e8f0; border-radius: 10px; padding: 28px 32px; margin-bottom: 28px;">
<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #718096; margin-bottom: 16px;">Regulatory Authority</div>
<table style="width: 100%; border-collapse: collapse;">
<tr style="border-bottom: 1px solid #e2e8f0;">
<td style="padding: 10px 12px; font-size: 13px; font-weight: 600; color: #718096; width: 35%;">Authority</td>
<td style="padding: 10px 12px; font-size: 14px; color: #2d3748;">Ministry of Healthcare of the Republic of Kazakhstan</td>
</tr>
<tr style="border-bottom: 1px solid #e2e8f0; background: #f7fafc;">
<td style="padding: 10px 12px; font-size: 13px; font-weight: 600; color: #718096;">Address</td>
<td style="padding: 10px 12px; font-size: 14px; color: #2d3748;">8 Mangilik El Avenue, Left Bank, Astana, Kazakhstan (Ministries Building, Entrance 5)</td>
</tr>
<tr>
<td style="padding: 10px 12px; font-size: 13px; font-weight: 600; color: #718096;">Authorized Person</td>
<td style="padding: 10px 12px; font-size: 14px; color: #2d3748;">Кенжеханова Алмагуль Жумахановна</td>
</tr>
</table>
</div>


==Regulatory Authority:==
<!-- Attachments -->
<div style="margin-bottom: 28px;">
<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #718096; margin-bottom: 14px;">Attachments</div>


Ministry of Healthcare of the Republic of Kazakhstan
<!-- SI Certificate -->
Address: 8 Mangilik El Avenue, Left Bank, Astana, Kazakhstan (Ministries Building, Entrance 5)
<div style="background: #ffffff; border: 1px solid #e2e8f0; border-radius: 10px; padding: 24px 28px; margin-bottom: 16px;">
Authorized Person: Кенжеханова Алмагуль Жумахановна
<div style="font-size: 15px; font-weight: 700; color: #1a1a2e; margin-bottom: 4px;">ТОО «TELTONIKA» Certificate</div>
 
<div style="font-size: 12px; color: #718096; margin-bottom: 16px;">TeltoHeart &mdash; Kazakhstan</div>
==Attachments==
<table style="width: 100%; border-collapse: separate; border-spacing: 8px;">
 
<tr>
{|style="margin: 0 auto;valign="left""
<td style="width: 50%; text-align: center; background: #f7fafc; border: 1px solid #e2e8f0; border-radius: 8px; padding: 8px;">[[File:ТОО_20«TELTONIKA»%_SI,_TeltoHeart_page_01.png|250px|KZ certificate page 1]]<div style="font-size: 11px; color: #718096; margin-top: 6px;">Page 1</div></td>
| [[File:ТОО_20«TELTONIKA»%_SI,_TeltoHeart_page_01.png |thumb|left|300px|x300px|KZ certificate page 1]]
<td style="width: 50%; text-align: center; background: #f7fafc; border: 1px solid #e2e8f0; border-radius: 8px; padding: 8px;">[[File:ТОО_20«TELTONIKA»%_SI,_TeltoHeart_page_02.png|250px|KZ certificate page 2]]<div style="font-size: 11px; color: #718096; margin-top: 6px;">Page 2</div></td>
| [[File:ТОО_20«TELTONIKA»%_SI,_TeltoHeart_page_02.png |thumb|left|300px|x300px|KZ certificate page 2]]
</tr>
|}
</table>
{|style="margin: 0 auto;valign="left""
<div style="margin-top: 16px;">
| [[File:KZ,_TeltoHeart_page_01.png |thumb|left|300px|x300px|KZ Registration certificate page 1]]
<span style="font-size: 14px; color: #2d3748;">Download PDF: </span>'''[[Media:ТОО_«TELTONIKA»_SI.pdf|ТОО «TELTONIKA» S →]]'''
| [[File:KZ,_TeltoHeart_page_02.png |thumb|left|300px|x300px|KZ Registration certificate page 2]]
</div>
|-
</div>
| [[File:KZ,_TeltoHeart_page_03.png |thumb|left|300px|x300px|KZ Registration certificate page 3]]
| [[File:KZ,_TeltoHeart_page_04.png |thumb|left|300px|x300px|KZ Registration certificate page 4]]
|}
 
 
You can find PDF version of the Kazachstan certificate <br>'''[[Media:ТОО_«TELTONIKA»_SI.pdf |ТОО «TELTONIKA» S]]'''. <br>
'''[[Media:Регистрационное_удостоверение_на_русском_языке_РК_МИ_(МТ)-0№028722_от_13.11.2024%203.pdf |Certificate]]'''. <br>


<!-- Registration Certificate -->
<div style="background: #ffffff; border: 1px solid #e2e8f0; border-radius: 10px; padding: 24px 28px;">
<div style="font-size: 15px; font-weight: 700; color: #1a1a2e; margin-bottom: 4px;">Registration Certificate</div>
<div style="font-size: 12px; color: #718096; margin-bottom: 16px;">РК МИ (МТ)-0№028722 &mdash; TeltoHeart ECG200</div>
<table style="width: 100%; border-collapse: separate; border-spacing: 8px;">
<tr>
<td style="width: 25%; text-align: center; background: #f7fafc; border: 1px solid #e2e8f0; border-radius: 8px; padding: 8px;">[[File:KZ,_TeltoHeart_page_01.png|200px|KZ Registration certificate page 1]]<div style="font-size: 11px; color: #718096; margin-top: 6px;">Page 1</div></td>
<td style="width: 25%; text-align: center; background: #f7fafc; border: 1px solid #e2e8f0; border-radius: 8px; padding: 8px;">[[File:KZ,_TeltoHeart_page_02.png|200px|KZ Registration certificate page 2]]<div style="font-size: 11px; color: #718096; margin-top: 6px;">Page 2</div></td>
<td style="width: 25%; text-align: center; background: #f7fafc; border: 1px solid #e2e8f0; border-radius: 8px; padding: 8px;">[[File:KZ,_TeltoHeart_page_03.png|200px|KZ Registration certificate page 3]]<div style="font-size: 11px; color: #718096; margin-top: 6px;">Page 3</div></td>
<td style="width: 25%; text-align: center; background: #f7fafc; border: 1px solid #e2e8f0; border-radius: 8px; padding: 8px;">[[File:KZ,_TeltoHeart_page_04.png|200px|KZ Registration certificate page 4]]<div style="font-size: 11px; color: #718096; margin-top: 6px;">Page 4</div></td>
</tr>
</table>
<div style="margin-top: 16px;">
<span style="font-size: 14px; color: #2d3748;">Download PDF: </span>'''[[Media:Регистрационное_удостоверение_на_русском_языке_РК_МИ_(МТ)-0№028722_от_13.11.2024%203.pdf|Registration Certificate →]]'''
</div>
</div>


</div>
</div>
<!--- [[Category:TeltoHeart Certification & Approvals]] --->
<!--- [[Category:TeltoHeart Certification & Approvals]] --->

Latest revision as of 13:41, 10 June 2026

Main Page > TeltoHeart > TeltoHeart KZ


TeltoHeart ECG200 – Kazakhstan Registration
Regulatory and registration information for the Republic of Kazakhstan.
Device Information
Manufacturer UAB TELTONIKA TELEMEDIC, Lithuania
Manufacturing Site UAB TELTONIKA TELEMEDIC, Lithuania
Authorized Representative in Kazakhstan ТОО TELTONIKA (Телтоника)
Device Name TeltoHeart ECG200
Device Type Wearable medical device (ECG monitor)
Risk Class Class 2a – Medium Risk
Registration
Certificate Number РК МИ (МТ)-0№028722
NICAD Number KZ09VBP00026308
Date of State Registration 13 November 2024, №N081094
Validity Indefinite
In accordance with the Code of the Republic of Kazakhstan "On the Health of the People and the Healthcare System" and the Law on Electronic Documents and Digital Signatures (7 January 2003), this certificate is legally equivalent to a paper document.
Scope of Use
The TeltoHeart ECG200 is registered and approved for use in medical practice across the territory of the Republic of Kazakhstan.
A list of consumables and components associated with the device is provided in the appendix to this registration certificate (Form 3, 1 sheet).
Regulatory Authority
Authority Ministry of Healthcare of the Republic of Kazakhstan
Address 8 Mangilik El Avenue, Left Bank, Astana, Kazakhstan (Ministries Building, Entrance 5)
Authorized Person Кенжеханова Алмагуль Жумахановна
Attachments
ТОО «TELTONIKA» Certificate
TeltoHeart — Kazakhstan
KZ certificate page 1
Page 1
 KZ certificate page 2
Page 2
Registration Certificate
РК МИ (МТ)-0№028722 — TeltoHeart ECG200
KZ Registration certificate page 1
Page 1
 KZ Registration certificate page 2
Page 2
 KZ Registration certificate page 3
Page 3
 KZ Registration certificate page 4
Page 4
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