Vietnam MOH registration 2402644ĐKLH/BYT-HTTB

Catheter for mapping the heart's electrical activity

VN: Catheter lập bản đồ điện sinh lý tim

Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Registered Oct 02, 2024

Registration details

Analysis ID: 2402644ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-230710-0037
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Authorized Representative: CÔNG TY TNHH JOHNSON & JOHNSON (VIỆT NAM)

Technical details

Intended Use: The product is intended to map the electrical activity of the heart's structures using multiple electrodes, meaning it records the heart's electrical signals or stimuli. The catheter is intended to collect ECG signals from the atria and ventricles of the heart. The high-density cardiac electrical mapping catheter PENTARAY NAV eco provides information about the position when used with compatible CARTO 3 EP navigation systems. (This catheter is not compatible with older versions of the CARTO 3 EP navigation system, specifically versions prior to 3.x).

Dates and status

Registration Date: Oct 02, 2024

About this record

Access comprehensive regulatory information for Catheter for mapping the heart's electrical activity 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 2402644ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH JOHNSON & JOHNSON (VIỆT NAM).

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