Vietnam MOH registration 2403009ĐKLH/BYT-HTTB

Pressure-activated wound healing foam

VN: Bộ xốp dùng cho điều trị vết thương bằng áp lực âm
Vietnam flagVietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·KCI USA, Inc.·Registered Nov 02, 2024
Registration details
Analysis ID
2403009ĐKLH/BYT-HTTB
Submission ID
000.00.04.G18-220323-0028
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
V.A.C. GranuFoam Dressing is part of the Negative Pressure Wound Therapy (NPWT) system. Therefore, the indications for V.A.C. GranuFoam Dressing are similar to those of other NPWT systems, as follows: Negative Pressure Wound Therapy Systems (NPWT Systems) ActiV.A.C., InfoV.A.C., V.A.C. ATS, V.A.C. Freedom, V.A.C. Simplicity, and V.A.C. VIA are integrated systems used in acute care, chronic wound care, and home care. When used on open wounds, the device creates an environment that promotes healing according to the second or third phase (delayed healing phase) by preparing the wound bed for rapid closure, reducing edema, promoting granulation tissue formation, and increasing blood flow, while simultaneously removing exudate and contaminants. The product is indicated for the treatment of various types of wounds: chronic, acute, traumatic, subacute, dehisced surgical wounds, partial-thickness burns (burns caused by diabetes, pressure sores, or venous stasis ulcers), and wounds caused by skin grafts and bone grafts. The V.A.C. GranuFoam Silver pad has the ability to effectively reduce the penetration of bacteria and can help reduce the risk of infection in the aforementioned types of wounds. For surgical wounds that have been sutured or stapled and continue to exude fluid or pus, the system helps manage the wound by creating a sealed environment and removing the exudate through the negative pressure method.
Dates and status
Registration Date
Nov 02, 2024
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About this record

Access comprehensive regulatory information for Pressure-activated wound healing foam 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 2403009ĐKLH/BYT-HTTB and manufactured by KCI USA, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH 3M VIỆT NAM.

This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including KCI USA, INC., GUANGZHOU RAINHOME PHARM & TECH CO., LTD., and 2 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.

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