Vietnam MOH registration 2403537ĐKLH/BYT-HTTB

Everolimus-Eluting Coronary Artery Stent

VN: Giá đỡ động mạch vành phủ thuốc Everolimus
I-Sync
Vietnam flagVietnam·Risk Class TTBYT Loại D·I-Sync - Everolimus Eluting Coronary Stent System·Purple MicroPort Cardiovascular Private Limited·Registered Nov 14, 2024
Registration details
Analysis ID
2403537ĐKLH/BYT-HTTB
Submission ID
000.00.04.G18-230814-0005
Product Type
I-Sync - Everolimus Eluting Coronary Stent System
Company information
Manufacturer Country
INDIA
Product Owner
Purple MicroPort Cardiovascular Private Limited
Authorized Representative
CÔNG TY TNHH VIMEDICAL
Technical details
Intended Use
The I-Sync everolimus-coated stent system is indicated to improve the coronary lumen diameter in symptomatic patients with coronary artery disease undergoing percutaneous transluminal coronary angioplasty (PTCA) in the setting of new coronary artery disease in the native coronary arteries of eligible patients.
Dates and status
Registration Date
Nov 14, 2024
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About this record

Access comprehensive regulatory information for Everolimus-Eluting Coronary Artery 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 2403537ĐKLH/BYT-HTTB and manufactured by Purple MicroPort Cardiovascular Private Limited. The authorized representative in Vietnam is CÔNG TY TNHH VIMEDICAL.

This page provides complete technical specifications, regulatory compliance details, 3 companies making similar products including Abbott Medical, Boston Scientific Limited, and 4 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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