Vietnam MOH registration 2402827ĐKLH/BYT-HTTB

Dual-chamber pacing device

VN: Máy tạo nhịp tim hai buồng

Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Biotronik SE & Co. KG·Registered Oct 22, 2024

Registration details

Analysis ID: 2402827ĐKLH/BYT-HTTB
Submission ID: 17001264/ĐKLH-BYT-TB-CT
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Biotronik SE & Co. KG
Manufacturer Country: Theo theo phụ lục
Product Owner: Biotronik SE & Co. KG
Authorized Representative: VĂN PHÒNG ĐẠI DIỆN BIOTRONIK ASIA PACIFIC PTE. LTD. TẠI THÀNH PHỐ HỒ CHÍ MINH

Technical details

Intended Use: Implantable cardiac rhythm devices are part of the implantable system, which includes a cardiac rhythm device and various types of leads to create the desired heart rhythm. The function of this system includes: the ability to sense the heart's intrinsic rhythm and to pace the heart with low-energy electrical impulses when necessary to ensure a stable heart rhythm or to support the intrinsic heart rhythm when needed. Implantation of a dual-chamber pacemaker is a symptomatic treatment option with the following objectives: • Monitoring heart rhythm and automatically detecting slow heart rhythms • Compensating for slow heart rhythms through the process of atrial pacing, ventricular pacing, or sequential atrial-ventricular pacing.

Dates and status

Registration Date: Oct 22, 2024

About this record

Access comprehensive regulatory information for Dual-chamber pacing 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 2402827ĐKLH/BYT-HTTB and manufactured by Biotronik SE & Co. KG. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN BIOTRONIK ASIA PACIFIC PTE. LTD. TẠI THÀNH PHỐ HỒ CHÍ MINH.

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