TeltoHeart KZ
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
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You can find PDF version of the Kazachstan certificate
ТОО «TELTONIKA» S.
Certificate.