Vietnam MOH registration 2402669ĐKLH/BYT-HTTB

Myocardial ischemia

VN: Bóng nong mạch vành
Vietnam flagVietnam·Risk Class TTBYT Loại D·Coronary Angioplasty Catheter RIVER·Balton Sp.zo.o.·Registered Oct 02, 2024
Registration details
Analysis ID
2402669ĐKLH/BYT-HTTB
Submission ID
17001823/ĐKLH-BYT-TB-CT
Product Type
Coronary Angioplasty Catheter RIVER
Product Code
CBR1.25x10140; CBR1.25x15140; CBR1.25x20140; CBR1.25x25140; CBR1.25x30140; CBR1.25x35140; CBR1.25x40140; CBR1.5x10140; CBR1.5x15140; CBR1.5x20140; CBR1.5x25140; CBR1.5x30140; CBR1.5x35140; CBR1.5x40140; CBR1.75x10140; CBR1.75x15140; CBR1.75x20140; CBR1.75x25140; CBR1.75x30140; CBR1.75x35140; CBR1.75x40140; CBR2.0x10140; CBR2.0x15140; CBR2.0x20140; CBR2.0x25140; CBR2.0x30140; CBR2.0x35140; CBR2.0x40140 CBR2.25x10140; CBR2.25x15140; CBR2.25x20140; CBR2.25x25140 CBR2.25x30140; CBR2.25x35140; CBR2.25x40140; CBR2.5x10140 CBR2.5x15140; CBR2.5x20140; CBR2.5x25140; CBR2.5x30140 CBR2.5x35140; CBR2.5x40140; CBR2.75x10140; CBR2.75x15140 CBR2.75x20140; CBR2.75x25140; CBR2.75x30140; CBR2.75x35140 CBR2.75x40140; CBR3.0x10140; CBR3.0x15140; CBR3.0x20140 CBR3.0x25140; CBR3.0x30140; CBR3.0x35140; CBR3.0x40140 CBR3.25x10140; CBR3.25x15140; CBR3.25x20140; CBR3.25x25140 CBR3.25x30140; CBR3.25x35140; CBR3.25x40140; CBR3.5x10140 CBR3.5x15140; CBR3.5x20140; CBR3.5x25140; CBR3.5x30140 CBR3.5x35140; CBR3.5x40140; CBR3.75x10140; CBR3.75x15140 CBR3.75x20140; CBR3.75x25140;CBR3.75x30140 ;CBR3.75x35140 CBR3.75x40140; CBR4.0x10140; CBR4.0x15140; CBR4.0x20140 CBR4.0x25140; CBR4.0x30140; CBR4.0x35140; CBR4.0x40140.
Company information
Manufacturer
Balton Sp.zo.o.
Manufacturer Country
POLAND
Product Owner
Balton Sp.zo.o.
Technical details
Intended Use
The bare-metal stent is used to improve the lumen diameter of the coronary arteries, including the narrowed and tortuous coronary arteries in symptomatic patients with coronary artery disease due to the progression of atherosclerosis, unoperated or restenosed coronary arteries (length ≤ 40 mm), with a reference vessel diameter ranging from 1.25 to 4.00 mm.
Dates and status
Registration Date
Oct 02, 2024
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About this record

Access comprehensive regulatory information for Myocardial ischemia 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 2402669ĐKLH/BYT-HTTB and manufactured by Balton Sp.zo.o.. The authorized representative in Vietnam is CÔNG TY TNHH TRANG THIẾT BỊ Y TẾ VÀ TƯ VẤN MÔI TRƯỜNG TÂM THY.

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