Vietnam MOH registration 2403030ĐKLH/BYT-HTTB

Implantable Heart Rhythm Monitor

VN: Máy theo dõi nhịp tim cấy vào cơ thể

Vietnam·Risk Class TTBYT Loại D·BIOMONITOR IV·Biotronik SE & Co. KG·Registered Nov 02, 2024

Registration details

Analysis ID: 2403030ĐKLH/BYT-HTTB
Submission ID: 17000311/ĐKLH-BYT-TB-CT
Product Type: BIOMONITOR IV
Product Code: 471155

Company information

Manufacturer: Biotronik SE & Co. KG
Manufacturer Country: GERMANY
Product Owner: Biotronik SE & Co. KG
Authorized Representative: VĂN PHÒNG ĐẠI DIỆN BIOTRONIK ASIA PACIFIC PTE. LTD. TẠI THÀNH PHỐ HỒ CHÍ MINH

Technical details

Intended Use: Implantable Heart Rhythm Monitor • Detects abnormal heart rhythms and monitors the occurrence and frequency of diseases related to bradycardia/tachycardia, as well as records the abnormal heart rhythms that occur when the patient experiences symptoms • Monitors the patient's activity and body temperature trends The implantable heart rhythm monitor achieves its intended use by detecting, analyzing, and recording the subcutaneous ECG along with long-term diagnostic data.

Dates and status

Registration Date: Nov 02, 2024

About this record

Access comprehensive regulatory information for Implantable Heart Rhythm Monitor 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 2403030ĐKLH/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.

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