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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