Vietnam MOH registration 2402802ĐKLH/BYT-HTTB

Drug-coated stent for coronary arteries (Sirolimus)

VN: Stent mạch vành phủ thuốc Sirolimus

D+Storm

Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·CG Bio Co., Ltd.·Registered Oct 22, 2024

Registration details

Analysis ID: 2402802ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-220812-0015
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: CG Bio Co., Ltd.
Manufacturer Country: Theo theo phụ lục
Product Owner: CG Bio Co., Ltd.
Authorized Representative: VĂN PHÒNG ĐẠI DIỆN DAEWOONG PHARMACEUTICAL CO., LTD. TẠI THÀNH PHỐ HỒ CHÍ MINH

Technical details

Intended Use: The product is used as a stent to maintain the patency of the coronary artery by being placed at the site of the original lesion (the initial lesion) in the coronary artery of the patient with chronic myocardial ischemia. The stent has a tubular structure and is expandable. It can be used in conjunction with a balloon catheter, ... to reduce restenosis.

Dates and status

Registration Date: Oct 22, 2024

About this record

Access comprehensive regulatory information for Drug-coated stent for coronary arteries (Sirolimus) 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 2402802ĐKLH/BYT-HTTB and manufactured by CG Bio Co., Ltd.. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN DAEWOONG PHARMACEUTICAL CO., LTD. TẠI THÀNH PHỐ HỒ CHÍ MINH.

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