Vietnam MOH registration 2403295ĐKLH/BYT-HTTB

Ultrasound-guided Catheter

VN: Catheter siêu âm lòng mạch

Vietnam·Risk Class TTBYT Loại D·Dualpro™ IVUS+NIRS Catheter·Infraredx, Inc.·Registered Nov 06, 2024

Registration details

Analysis ID: 2403295ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-231215-0020
Product Type: Dualpro™ IVUS+NIRS Catheter
Product Code: TVC-C195-42

Company information

Manufacturer: Infraredx, Inc.
Manufacturer Country: UNITED STATES
Product Owner: Infraredx, Inc.
Authorized Representative: CÔNG TY TNHH NIPRO SALES VIỆT NAM

Technical details

Intended Use: The Dualpro™ IVUS + NIRS catheter is a single-use device designed to be used with the Makoto™ IVUS + NIRS integrated intravascular ultrasound system. The Makoto IVUS + NIRS integrated intravascular ultrasound system is designed to assess the near-infrared characteristics of the coronary arteries in patients undergoing percutaneous coronary intervention. The system is designed to detect lipid-core plaques; assess the degree of lipid core in the coronary arteries; and identify patients with lipid-core plaques at increased risk of major cardiovascular events. The system is designed to assess intravascular ultrasound of intraluminal pathology. Intravascular ultrasound images are indicated in patients who are candidates for percutaneous coronary intervention procedures.

Dates and status

Registration Date: Nov 06, 2024

About this record

Access comprehensive regulatory information for Ultrasound-guided Catheter 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 2403295ĐKLH/BYT-HTTB and manufactured by Infraredx, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH NIPRO SALES VIỆT NAM.

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