Single-chamber cardiac pacing device - Vietnam Registration 2400450ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Single-chamber cardiac 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 2400450ĐKLH/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, 1 companies making similar products including 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.
Device Details
Registration Details
2400450ĐKLH/BYT-HTTB
17001267/ĐKLH-BYT-TB-CT
Theo theo phụ lục
Theo phụ lục
Technical Details
Implantable cardiac rhythm generators are a part of the implantable system, which includes the cardiac rhythm generator and the signal-carrying wires to generate the heartbeat as required. The function of the system is first to sense the intrinsic heart rate and second to provide pacing by low-energy electrical impulses when needed to ensure a stable heartbeat or to support the intrinsic heartbeat when needed. Implantation of a cardiac rhythm generator is a symptomatic treatment with the following objectives: •Monitoring the heart rate and automatically detecting slow heart rate •Compensating for slow heart rate through the atrium or ventricle (monochamber device)
Dates and Status
Apr 10, 2024