Vietnam MOH registration 2402081ĐKLH/BYT-HTTB

Heart Rate Re-synchronization Device

VN: Máy tạo nhịp tái đồng bộ tim

Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·St. Jude Medical Cardiac Rhythm Management Division·Registered Aug 27, 2024

Registration details

Analysis ID: 2402081ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-230425-0008
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: St. Jude Medical Cardiac Rhythm Management Division
Manufacturer Country: Theo theo phụ lục
Product Owner: St. Jude Medical Cardiac Rhythm Management Division
Authorized Representative: CÔNG TY TNHH THƯƠNG MẠI VÀ DỊCH VỤ Y TẾ DMEC

Technical details

Intended Use: Used to deliver electrical impulses to directly stimulate the left atrium and the two ventricles through the electrode wire, aiming to treat bradycardia, and to restore the normal rhythm between the atrium and ventricles and between the two ventricles. It is indicated for patients with bradycardia and loss of coordination between the atrium and ventricles and between the two ventricles.

Dates and status

Registration Date: Aug 27, 2024

About this record

Access comprehensive regulatory information for Heart Rate Re-synchronization Device in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại D medical device is registered under number 2402081ĐKLH/BYT-HTTB and manufactured by St. Jude Medical Cardiac Rhythm Management Division. The authorized representative in Vietnam is CÔNG TY TNHH THƯƠNG MẠI VÀ DỊCH VỤ Y TẾ DMEC.

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