Vietnam MOH registration 2403696ĐKLH/BYT-HTTB

The Ear Canal Occlusion Probe

VN: Bộ dù đóng lỗ thông liên nhĩ

Vietnam·Risk Class TBYT Loại D·Theo theo phụ lục·Lifetech Scientific (Shenzhen) Co., Ltd.·Registered Nov 19, 2024

Registration details

Analysis ID: 2403696ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-240424-0005
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Lifetech Scientific (Shenzhen) Co., Ltd.
Manufacturer Country: Theo theo phụ lục
Product Owner: Lifetech Scientific (Shenzhen) Co., Ltd.
Authorized Representative: CÔNG TY CỔ PHẦN THƯƠNG MẠI VÀ DỊCH VỤ GIA HÂN

Technical details

Intended Use: 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

Registration Date: Nov 19, 2024

About this record

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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