Vietnam MOH registration 2400600ĐKLH/BYT-HTTB

Pressure-activated wound healing foam pad

VN: Bộ xốp điều trị vết thương bằng áp lực âm

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·KCI USA, INC.·Registered May 08, 2024

Registration details

Analysis ID: 2400600ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-220310-0004
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: KCI USA, INC.
Manufacturer Country: Theo theo phụ lục
Product Owner: KCI USA, INC.
Authorized Representative: CÔNG TY TNHH 3M VIỆT NAM

Technical details

Intended Use: The Pressure-Induced Wound Healing Sponge is a component of the SNAP Therapy System. Therefore, the intended use of the Pressure-Induced Wound Healing Sponge is similar to the intended use of the entire system. As follows: The SNAP™ Therapy System is indicated for patients with wounds that can be treated and healed by negative pressure, particularly when the device can promote the healing process by removing exudate, infection-causing organisms, and sloughed tissue. The SNAP™ Therapy System is indicated to remove a portion of the exudate from chronic, acute, traumatic, subacute, and dehisced wounds, surgical wounds, ulcers (diabetic, venous, or pressure sores), surgical wounds that have healed by secondary intention, and wounds with slough and graft tissue.

Dates and status

Registration Date: May 08, 2024

About this record

Access comprehensive regulatory information for Pressure-activated wound healing foam pad in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2400600ĐKLH/BYT-HTTB and manufactured by KCI USA, INC.. The authorized representative in Vietnam is CÔNG TY TNHH 3M VIỆT NAM.

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