Vietnam MOH registration 2403500ĐKLH/BYT-HTTB

Drug-coated Coronary Artery Stent (Novolimus)

VN: Khung giá đỡ mạch vành phủ thuốc Novolimus

Vietnam·Risk Class TBYT Loại D·Theo theo phụ lục·Elixir Medical Corporation·Registered Nov 14, 2024

Registration details

Analysis ID: 2403500ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-231229-0011
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Elixir Medical Corporation
Manufacturer Country: Theo theo phụ lục
Product Owner: Elixir Medical Corporation
Authorized Representative: CÔNG TY CỔ PHẦN ĐẦU TƯ PHÁT TRIỂN TMT VIỆT NAM

Technical details

Intended Use: The drug-eluting coronary stent with Novolimus is a permanently implanted device that combines the drug, Novolimus, and aims to improve the coronary artery diameter in patients with symptomatic coronary artery disease.

Dates and status

Registration Date: Nov 14, 2024

About this record

Access comprehensive regulatory information for Drug-coated Coronary Artery Stent (Novolimus) in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại D medical device is registered under number 2403500ĐKLH/BYT-HTTB and manufactured by Elixir Medical Corporation. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN ĐẦU TƯ PHÁT TRIỂN TMT VIỆT NAM.

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