JAMES ALEXANDER CORP.

James Alexander Corp. specializes in synthetic-polymer liquid barrier dressings, which are designed to shield wounds from moisture while keeping the wound environment moist. Their portfolio also includes a dispensing solution for applying these dressings and a combination tool—specifically, a 6x magnifier paired with precision tweezers—used in medical procedures.

James Alexander Corp. is based in the United States, which means its devices fall under FDA jurisdiction. The FDA classifies their products as either Class I or Class II (N), with regulatory pathways including the 510(k) premarket notification process for some devices and UDI requirements for others, ensuring compliance with U.S. medical device regulations.

James Alexander Corp.’s devices are listed in the FDA’s 510(k) registry for certain products and the FDA’s Unique Device Identifier (UDI) system for others. These registries help track and verify compliance with U.S. medical device regulations, ensuring transparency and traceability for healthcare providers and authorities.

The FDA classifies James Alexander Corp.’s devices as either Class I (generally low-risk) or Class II (N) under the National Bacteriostatic Category, which requires special controls to ensure safety and effectiveness. This classification determines the regulatory pathway—such as 510(k) submissions or UDI requirements—ensuring appropriate oversight based on the device’s risk level.