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Three-chambered cardiac pacemaker with heart resynchronization function - Vietnam Registration 2402074ĐKLH/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 2402074ĐKLH/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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2402074ĐKLH/BYT-HTTB
Registration Details
Vietnam MOH Registration: 2402074ĐKLH/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

2402074ĐKLH/BYT-HTTB

17001299/ĐKLH-BYT-TB-CT

Theo theo phụ lục

Theo phụ lục

Company Information

Theo theo phụ lục

Biotronik SE & Co. KG

Technical Details

These are the implanted cardiac resynchronization therapy (CRT: HF-T and HF-T QP) and the implanted cardiac resynchronization therapy (CRT-P: HF-T and HF-T QP). The cardiac resynchronization therapy (CRT) device is a part of the implanted cardiac resynchronization therapy system, which includes the CRT device and the signal transmission wires. The main function of the system is first to sense the intrinsic heart rate and second to provide low-energy electrical pacing, as well as to provide low-energy anti-tachycardia pacing when necessary to ensure a stable heart rate or to support the intrinsic heart rate when necessary. The CRT-P systems have all the functions mentioned and in addition provide permanent sensing and pacing of the left ventricle. Implantation of the cardiac resynchronization therapy device is a symptomatic treatment with the following objectives: •Sensing and recording the heart rate and automatically detecting slow and fast heartbeats (PMs and CRT-Ps) •Compensating for slow heart rate through atrial or ventricular or sequential atrioventricular pacing (AV) (PM and CRT-P) •Physiological pacing (LBB(A)P) by stimulating the conduction system (PM and CRT-P) •Terminating fast atrial tachycardia (AT/AF) through anti-tachycardia pacing (ATP) in the atrium (PMs and CRT-Ps) •Cardiac resynchronization through multi-site ventricular pacing or through physiological pacing (CRT-Ps, e.g., biventricular pacing)

Dates and Status

Aug 27, 2024

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