FDA.reportPublic FDA data

Genewel Co.,Ltd.

GUDID#

Medifoam - Medifoam is indicated for the management of exuding wounds such as ulcers, burns, surgical/traumatic/acute, lacerations, abrasions, etc. It readily absorbs exudate, providing a moist wound interface that produces an optimal wound healing environment. To help adhesion, a non-woven fabric for fixation is enclosed with the product. Medifoam is a sterile, but Non-woven fabric is a non-sterile. This is single-use product, do not re-use. This product does not include a hydrophilic wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

Genewel Co.,Ltd.

2022-10-30

Medifoam H beauty - Medifoam H beauty is intended to manage and assist in wound healing by absorbing exudate in wounds for minimal wound maceration, allowing wound debridement, and creating a moist wound healing environment. This product is provided sterile. After application, this device cannot be reused. A pair of tweezers are included with the product to help pick up the product or packaging, and the tweezers are non-sterile and not a medical device. The Medifoam H beauty does not include a hydrophilic wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

Genewel Co.,Ltd.

2022-10-30

Medifoam - Medifoam is indicated for the management of exuding wounds such as ulcers, burns, surgical/traumatic/acute, lacerations, abrasions, etc. It readily absorbs exudate, providing a moist wound interface that produces an optimal wound healing environment. To help adhesion, a non-woven fabric for fixation is enclosed with the product. Medifoam is a sterile, but Non-woven fabric is a non-sterile. This is single-use product, do not re-use. This product does not include a hydrophilic wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

Genewel Co.,Ltd.

2022-10-30

Medifoam H beauty - Medifoam H beauty is intended to manage and assist in wound healing by absorbing exudate in wounds for minimal wound maceration, allowing wound debridement, and creating a moist wound healing environment. This product is provided sterile. After application, this device cannot be reused. A pair of tweezers are included with the product to help pick up the product or packaging, and the tweezers are non-sterile and not a medical device. The Medifoam H beauty does not include a hydrophilic wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

Genewel Co.,Ltd.

2022-10-30