Three-chambered cardiac pacemaker with heart resynchronization function - Vietnam Registration 2402340ĐKLH/BYT-HTTB

Access comprehensive regulatory information for Three-chambered cardiac pacemaker with heart resynchronization function 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 2402340ĐKLH/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.

This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including Biotronik SE & Co. KG, Biotronik SE & Co. KG, and 2 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.

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2402340ĐKLH/BYT-HTTB

Registration Details

Vietnam MOH Registration: 2402340ĐKLH/BYT-HTTB

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Device Details

Three-chambered cardiac pacemaker with heart resynchronization function

VN: Máy tạo nhịp tim ba buồng có chức năng tái đồng bộ tim

Risk Class TTBYT Loại D

Registration Details

Analysis ID

2402340ĐKLH/BYT-HTTB

Submission ID

17001274/ĐKLH-BYT-TB-CT

Product Type

Theo theo phụ lục

Product Code

Theo phụ lục

Technical Details

Intended Use

Implantable cardiac rhythm devices are a part of the implantable system, which includes a cardiac rhythm device and various types of electrodes 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 three-chamber cardiac rhythm device 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 • Re-synchronizing the heart through multi-site ventricular pacing.