Vietnam MOH registration 2402799ĐKLH/BYT-HTTB

PTCA Guiding Catheter with Shapeable Balloon

VN: Ống thông kèm bóng tạo hình mạch vành PTCA

Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Shanghai MicroPort Medical (Group) Co., Ltd.·Registered Oct 22, 2024

Registration details

Analysis ID: 2402799ĐKLH/BYT-HTTB
Submission ID: 18006178/ĐKLH-BYT-TB-CT
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Shanghai MicroPort Medical (Group) Co., Ltd.
Manufacturer Country: Theo theo phụ lục
Product Owner: Shanghai MicroPort Medical (Group) Co., Ltd.
Authorized Representative: CÔNG TY TNHH ANDAMAN MEDICAL VIỆT NAM

Technical details

Intended Use: The PTCA guidewire with a shapeable balloon is indicated for use with the balloon pre-dilation in patients with atherosclerotic stenosis of the coronary arteries, in the presence of the following coronary artery diseases: • Stable or unstable angina • Acute or chronic myocardial infarction • One or more stenoses in the coronary arteries • Re-stenosis of the coronary arteries after coronary artery bypass surgery (CABG) • Re-stenosis of the coronary arteries after PTCA angioplasty • Total occlusion of the main coronary artery

Dates and status

Registration Date: Oct 22, 2024

About this record

Access comprehensive regulatory information for PTCA Guiding Catheter with Shapeable Balloon 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 2402799ĐKLH/BYT-HTTB and manufactured by Shanghai MicroPort Medical (Group) Co., Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH ANDAMAN MEDICAL VIỆT NAM.

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