Single-chamber cardiac pacing device
Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Biotronik SE & Co. KG·Registered Apr 10, 2024- Analysis ID
- 2400450ĐKLH/BYT-HTTB
- Submission ID
- 17001267/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 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)
- Registration Date
- Apr 10, 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 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.