Vietnam MOH registration 2403658ĐKLH/BYT-HTTB

Silver-coated mesh pad

VN: Gạc lưới tẩm muối bạc

Vietnam·Risk Class TBYT Loại D·Theo theo phụ lục·Registered Nov 19, 2024

Registration details

Analysis ID: 2403658ĐKLH/BYT-HTTB
Submission ID: 17004997/ĐKLH-BYT-TB-CT
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Authorized Representative: VĂN PHÒNG ĐẠI DIỆN HCP HEALTHCARE ASIA PTE. LTD. TẠI THÀNH PHỐ HỒ CHÍ MINH

Technical details

Intended Use: UrgoTul Ag/Silver is indicated for the treatment of external skin wounds, due to its primary effect of protecting the wound and promoting healing in a moist environment. UrgoTul Ag/Silver is primarily used for wounds at risk or showing clinical signs of local infection, thanks to the antibacterial action of the silver ions, which help reduce the number of local bacteria and the risk of infection. External skin wounds include: Chronic wounds (such as foot ulcers, pressure sores, and diabetic foot ulcers); Acute wounds (partial-thickness burns (second-degree burns), wounds from trauma, surgical wounds). For surgical wounds, the use of UrgoTul Ag/Silver should be carefully considered in specific surgical situations involving high-risk patients undergoing complex procedures and should be used with caution, limited to a minimum extent, and should not be used as a surgical sponge for heavily bleeding wounds. Due to its flexible nature, UrgoTul Ag/Silver is suitable for use in difficult-to-bandage areas (e.g., fingers, or over bony prominences), or for deep or sunken wounds. UrgoTul Ag/Silver requires the use of an appropriate absorbent pad to manage the amount of exudate from the wound (the fluid at the wound site) and should be secured with a bandage if the absorbent pad is not adherent (e.g., roll bandage, gauze tube or flat bandage).

Dates and status

Registration Date: Nov 19, 2024

About this record

Access comprehensive regulatory information for Silver-coated mesh pad in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại D medical device is registered under number 2403658ĐKLH/BYT-HTTB. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN HCP HEALTHCARE ASIA PTE. LTD. TẠI THÀNH PHỐ HỒ CHÍ MINH.

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