Vietnam MOH registration 2403510ĐKLH/BYT-HTTB

Despite closing the interventricular septal defect

VN: Dù đóng lỗ thông liên thất

Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Shanghai Shape Memory Alloy Co.,Ltd·Registered Nov 14, 2024

Registration details

Analysis ID: 2403510ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-240721-0001
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Shanghai Shape Memory Alloy Co.,Ltd
Manufacturer Country: Theo theo phụ lục
Product Owner: Shanghai Shape Memory Alloy Co.,Ltd
Authorized Representative: CÔNG TY TNHH THIẾT BỊ Y TẾ THÁI VÂN PHONG

Technical details

Intended Use: The plug to close the pericardial tunnel communication defect is intended to be used to close the pericardial tunnel communication defect by the minimally invasive catheter. The plug to close the pericardial tunnel defect of the myocardium is indicated for patients with complex ventricular septal defect (VSD) who have a significant defect size requiring closure (large left-to-right shunt volume, increased pulmonary pressure and/or clinical symptoms of congestive heart failure), and who are considered to be at high risk for surgical closure of the defect by trans-catheter atrial or aortic valve surgery, based on their anatomical status and/or overall medical condition.

Dates and status

Registration Date: Nov 14, 2024

About this record

Access comprehensive regulatory information for Despite closing the interventricular septal defect 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 2403510ĐKLH/BYT-HTTB and manufactured by Shanghai Shape Memory Alloy Co.,Ltd. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ Y TẾ THÁI VÂN PHONG.

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