Vietnam MOH registration 2403313ĐKLH/BYT-HTTB

Peripheral Vascular Hypertension

VN: Bóng nong mạch ngoại vi
Vietnam flagVietnam·Risk Class TTBYT Loại D·Z-5 Atrioseptostomy Catheter·NUMED, INC.·Registered Nov 06, 2024
Registration details
Analysis ID
2403313ĐKLH/BYT-HTTB
Submission ID
19011016/ĐKLH-BYT-TB-CT
Product Type
Z-5 Atrioseptostomy Catheter
Product Code
SPT002, SPT003.
Company information
Manufacturer
NUMED, INC.
Manufacturer Country
Theo theo phụ lục
Product Owner
NUMED, INC.
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.
Dates and status
Registration Date
Nov 06, 2024
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About this record

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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