Sirolimus-Eluting Coronary Stent
Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Kamal Encon Industries Limited·Registered Aug 27, 2024- Analysis ID
- 2402032ĐKLH/BYT-HTTB
- Submission ID
- 18006199/ĐKLH-BYT-TB-CT
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Kamal Encon Industries Limited
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Kamal Encon Industries Limited
- Authorized Representative
- CÔNG TY TNHH ANDAMAN MEDICAL VIỆT NAM
- Intended Use
- 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.
- Registration Date
- Aug 27, 2024
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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.