Vietnam MOH registration 2400963ĐKLH/BYT-HTTB

The guidewire used in coronary angioplasty

VN: Vi ống thông dùng trong can thiệp mạch vành

Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Hi-lex Corporation·Registered Jul 21, 2024

Registration details

Analysis ID: 2400963ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-231013-0001
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Hi-lex Corporation
Manufacturer Country: Theo theo phụ lục
Product Owner: Hi-lex Corporation
Authorized Representative: CÔNG TY TNHH AMETHYST MEDICAL VIỆT NAM

Technical details

Intended Use: This product is a super small microcatheter used to capture the selectively small blood vessels with a diameter of 1 ~ 2 mm and to support the guidewire in PCI (percutaneous coronary intervention). The tip of the catheter is designed to be easily visible under X-ray. It should be removed from the body immediately after use and should not remain in the blood vessels for a long time.

Dates and status

Registration Date: Jul 21, 2024

About this record

Access comprehensive regulatory information for The guidewire used in coronary angioplasty 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 2400963ĐKLH/BYT-HTTB and manufactured by Hi-lex Corporation. The authorized representative in Vietnam is CÔNG TY TNHH AMETHYST MEDICAL VIỆT NAM.

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