Vietnam MOH registration 2301315ĐKLH/BYT-HTTB

Aneurysm of the Aorta

VN: Bóng nong van động mạch chủ
Vietnam flagVietnam·Risk Class TTBYT Loại D·Valver Valvuloplasty Catheters·Balton Sp.zo.o.·Registered Oct 11, 2023
Registration details
Analysis ID
2301315ĐKLH/BYT-HTTB
Submission ID
000.00.04.G18-211105-0016
Product Type
Valver Valvuloplasty Catheters
Product Code
VALB231823X40110; VALB252025X40110; VALB282328X40110; VALB312631X40110.
Company information
Manufacturer
Balton Sp.zo.o.
Manufacturer Country
POLAND
Technical details
Intended Use
Translating the text to English: Endovascular Aortic Balloon Dilatation is a procedure performed in the treatment of various types of aortic valve stenosis. This procedure has rather limited indications, including: The situation where the patient is prepared for a valve repair surgery, but the patient's condition requires immediate intervention; Severe aortic stenosis with significant symptoms; The event where the patient has severe aortic valve stenosis requiring urgent surgery unrelated to the heart; Severe aortic valve stenosis in patients who, despite the severity of the condition, do not meet the criteria for heart valve replacement surgery; In children and adolescents - to allow for a delay in valve repair surgery for a period of a few to several years
Dates and status
Registration Date
Oct 11, 2023
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About this record

Access comprehensive regulatory information for Aneurysm of the Aorta 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 2301315ĐKLH/BYT-HTTB and manufactured by Balton Sp.zo.o..

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