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Sirolimus-Eluting Coronary Stent - Vietnam Registration 2402032ĐKLH/BYT-HTTB

Access comprehensive regulatory information for Sirolimus-Eluting Coronary Stent 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 2402032ĐKLH/BYT-HTTB and manufactured by Kamal Encon Industries Limited. The authorized representative in Vietnam is CÔNG TY TNHH ANDAMAN MEDICAL VIỆT NAM.

This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including Theo theo phụ lục, Theo phụ lục, 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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2402032ĐKLH/BYT-HTTB
Registration Details
Vietnam MOH Registration: 2402032ĐKLH/BYT-HTTB
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Device Details

Sirolimus-Eluting Coronary Stent
VN: Giá đỡ mạch vành phủ thuốc Sirolimus
Risk Class TTBYT Loại D

Registration Details

2402032ĐKLH/BYT-HTTB

18006199/ĐKLH-BYT-TB-CT

Theo theo phụ lục

Theo phụ lục

Company Information

Theo theo phụ lục

Kamal Encon Industries Limited

Technical Details

The Sirolimus-coated stent is designed for use in patients who are candidates for percutaneous transluminal coronary angioplasty (PTCA). The product is indicated to improve the coronary artery lumen in patients with symptomatic ischemic heart disease due to de novo, fragmented lesions, with a length ≤ 47 mm, in the native coronary arteries with a reference vessel diameter ranging from 2.00 to 4.50 mm.

Dates and Status

Aug 27, 2024

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