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==TeltoHeart ECG200 – Regulatory and Registration 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
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.

==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:==

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==

{|style="margin: 0 auto;valign="left""
| [[File:ТОО_20«TELTONIKA»%_SI,_TeltoHeart_page_01.png |thumb|left|300px|x300px|KZ certificate page 1]]
| [[File:ТОО_20«TELTONIKA»%_SI,_TeltoHeart_page_02.png |thumb|left|300px|x300px|KZ certificate page 2]]
|}
{|style="margin: 0 auto;valign="left""
| [[File:KZ,_TeltoHeart_page_01.png |thumb|left|300px|x300px|KZ Registration certificate page 1]]
| [[File:KZ,_TeltoHeart_page_02.png |thumb|left|300px|x300px|KZ Registration certificate page 2]]
|-
| [[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>


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