Single-chamber cardiac pacing device
Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Biotronik SE & Co. KG·Registered Oct 22, 2024- Analysis ID
- 2402824ĐKLH/BYT-HTTB
- Submission ID
- 17001604/ĐKLH-BYT-TB-CT
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- 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
- Intended Use
- Implantable cardiac rhythm devices are 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. Implantable single-chamber cardiac rhythm devices are 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 or ventricular pacing
- Registration Date
- Oct 22, 2024
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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 2402824ĐKLH/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.