Peripheral Vascular Hypertension - Vietnam Registration 2403313ĐKLH/BYT-HTTB

Access comprehensive regulatory information for Peripheral Vascular Hypertension 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 2403313ĐKLH/BYT-HTTB and manufactured by NUMED, INC.. The authorized representative in Vietnam is CÔNG TY TNHH DƯỢC PHẨM VÀ TRANG THIẾT BỊ Y TẾ HOÀNG ĐỨC.

This page provides complete technical specifications, regulatory compliance details, 5 companies making similar products including Theo theo phụ lục, Medtronic Plc, and 5 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.

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2403313ĐKLH/BYT-HTTB

Registration Details

Vietnam MOH Registration: 2403313ĐKLH/BYT-HTTB

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Device Details

Peripheral Vascular Hypertension

VN: Bóng nong mạch ngoại vi

Risk Class TTBYT Loại D

Registration Details

Analysis ID

2403313ĐKLH/BYT-HTTB

Submission ID

19011016/ĐKLH-BYT-TB-CT

Product Type

Z-5 Atrioseptostomy Catheter

Product Code

SPT002, SPT003.

Technical Details

Intended Use

It is indicated for the treatment of certain congenital heart defects using a catheter-based procedure called the balloon valvuloplasty of the interventricular septum, which is performed at some pediatric cardiology centers. The balloon valvuloplasty of the interventricular septum is used in combination with a diagnostic catheter and is performed after the diagnosis of certain congenital heart defects: transposition of the great arteries, complete anomalous pulmonary venous return, tricuspid valve atresia, mitral valve stenosis, bicuspid valve atresia, and pulmonary valve stenosis with an intact interventricular septum. SPT002 - 9.5mm is primarily used in infants weighing less than 2kg.