ALVIX LABORATORIES, LLC

Alvix Laboratories, LLC specializes in non-sterile wound care products. Their primary offerings include hydrogel-based wound gels, such as AzaDrox Rx and BasaDrox Rx, which are designed for topical application to wounds to support healing. They also produce osmotic skin dressings, like KamDoy Rx Skin Emulsion, intended for skin hydration and repair. These products focus on maintaining moisture balance and aiding tissue regeneration.

Alvix Laboratories, LLC is based in the United States. Their devices, including the hydrogel dressings and skin emulsions, are manufactured domestically in compliance with U.S. medical device regulations. The company’s focus on local production ensures alignment with regulatory standards and supply chain consistency.

Alvix Laboratories, LLC’s devices fall under Class II (U) classification in the FDA’s regulatory framework. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness. The classification is determined based on factors like the device’s intended use, potential risks, and the level of regulation needed to mitigate those risks.

Yes, Alvix Laboratories, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency in the supply chain and regulatory compliance. Listing in this database is a requirement for many Class II devices in the U.S.