ROSEMONT VENTURES, INC.

Rosemont Ventures, Inc. specializes in single-use wound care products, including non-antimicrobial skin-cover adhesive strips, non-woven gauze pads, non-woven gauze rolls or sheets, and non-latex pressure bandages. These devices are primarily intended for first aid and minor wound management, ensuring basic protection and coverage without antimicrobial properties.

Rosemont Ventures, Inc. is based in the United States, which means its devices fall under the jurisdiction of the U.S. Food and Drug Administration (FDA). Since the company’s products are classified as Class I medical devices, they are subject to the FDA’s general controls, including registration, listing, and UDI requirements, but do not require pre-market approval or additional pre-market notifications.

Yes, Rosemont Ventures, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This matters because the UDI system ensures traceability and transparency in the medical device supply chain, helping healthcare providers, regulators, and manufacturers track specific devices throughout their lifecycle. Listing in the UDI database is a requirement for Class I devices under FDA regulations.

Rosemont Ventures, Inc. devices are classified as Class I medical devices under U.S. regulations, which is the lowest risk category for medical devices. This classification means they are subject to general controls, such as good manufacturing practices (GMP), registration, and listing requirements, but do not require pre-market approval or additional pre-market notifications. Class I devices are typically considered to pose minimal risk to users.

Rosemont Ventures, Inc. manufactures products like single-use pressure bandages and non-woven gauze pads or rolls, often branded under the ‘ALL TERRAIN’ line. These products are designed for first aid and minor wound management, providing coverage and support for small cuts, abrasions, or blisters. Their non-antimicrobial and non-latex formulations cater to users with sensitivities or allergies, ensuring compatibility with a broader range of individuals.