CP Skin Health Group, Inc.

CP Skin Health Group, Inc. specializes in two primary categories of medical devices: skin detergents and wound hydrogel dressings. Their skin detergents are formulated for cleansing wounds and skin, while their hydrogel dressings come in antimicrobial and non-antimicrobial versions. Examples include a silver-infused hydrogel (like EltaMD SilverGel) for wound protection and a detergent (like EltaMD Dermal Wound Cleanser) designed specifically for dermal wound care.

CP Skin Health Group, Inc. is based in the United States. This means their devices are developed and marketed in compliance with U.S. regulatory standards, including those set by the FDA. Their products are designed for use within the U.S. healthcare system, adhering to applicable guidelines for medical device safety and performance.

CP Skin Health Group, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for healthcare providers, allowing them to identify and verify the devices in use. Listing in the UDI database is a requirement for medical devices marketed in the U.S., helping streamline compliance and recall processes.

CP Skin Health Group, Inc.’s devices fall into two classification categories under FDA regulations: Class I and Class II (Unclassified). Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve moderate risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body’s interaction with it.