Vietnam MOH registration 240000757/PCBB-HCM

Integrated Intravascular Ultrasound and Near-Infrared Spectroscopy (IVUS + NIRS)

VN: Hệ thống siêu âm lòng mạch tích hợp cận hồng ngoại IVUS + NIRS

Vietnam·Risk Class TTBYT Loại B·Makoto Intravascular Imaging System·Infraredx, Inc.·Registered Apr 11, 2024

Registration details

Analysis ID: 240000757/PCBB-HCM
Submission ID: 000.00.19.H29-240405-0003
Product Type: Makoto Intravascular Imaging System
Product Code: TVC-MC10, TVC-MC10i

Company information

Manufacturer: Infraredx, Inc.
Manufacturer Country: Theo theo phụ lục
Product Owner: Infraredx, Inc.
Authorized Representative: CÔNG TY TNHH NIPRO SALES VIỆT NAM

Technical details

Intended Use: The Makoto Intravascular Imaging System™ is designed to assess intravascular near-infrared arterial wall imaging in patients undergoing invasive coronary angiography. a) The system is designed to detect the core lipid plaque. b) The system aims to assess the core lipid content of the coronary arteries. c) The system aims to identify patients and plaques at increased risk for significant adverse cardiac events. The system is designed to assess intravascular pathological coronary artery disease. a) Intravascular ultrasound imaging is indicated in patients who are candidates for percutaneous coronary intervention.

Dates and status

Registration Date: Apr 11, 2024

About this record

Access comprehensive regulatory information for Integrated Intravascular Ultrasound and Near-Infrared Spectroscopy (IVUS + NIRS) in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240000757/PCBB-HCM and manufactured by Infraredx, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH NIPRO SALES VIỆT NAM.

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