The Ear Canal Occlusion Probe - Vietnam Registration 2403696ĐKLH/BYT-HTTB
Access comprehensive regulatory information for The Ear Canal Occlusion Probe in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại D medical device is registered under number 2403696ĐKLH/BYT-HTTB and manufactured by Lifetech Scientific (Shenzhen) Co., Ltd.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN THƯƠNG MẠI VÀ DỊCH VỤ GIA HÂN.
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Device Details
Registration Details
2403696ĐKLH/BYT-HTTB
000.00.04.G18-240424-0005
Theo theo phụ lục
Theo phụ lục
Technical Details
HeartRTM Occluder: The goal of the HeartRTM Occluder: The HeartRTM Occluder is a skin-penetrating, catheter-based device designed to close the left atrial appendage in patients with a concealed atrial septal defect (ASD) or in patients who have undergone multiple Fontan procedures and now require closure of the defect. Patients who are candidates for the HeartRTM Occluder have evidence of secondary mitral regurgitation and clinical evidence of right ventricular volume overload; The goal of the HeartRTM Occluder Delivery System: The SteerEase Delivery System is designed to approach the cardiovascular system or the peripheral vascular system and will create a pathway to deliver the device
Dates and Status
Nov 19, 2024