PHARMCHEM, INC.

PharmChem, Inc. specializes in two primary categories of medical devices: transparent adhesive overlays for wound or medical site coverage, such as the PharmChem, Inc. Transparent Overlay Film with Cutout, and drug-testing specimen collection kits for identifying substances in sweat samples, like the PharmChek (R) Drugs of Abuse Sweat Patch. These products serve distinct purposes—one for physical protection and the other for diagnostic testing.

PharmChem, Inc. is based in the United States, which means its devices are subject to U.S. medical device regulations. Since all its listed devices fall under Class I classification, they are governed by the FDA’s general controls, including registration, listing, and UDI requirements. The company’s U.S. location ensures alignment with FDA-specific regulatory pathways.

PharmChem, Inc.’s devices are registered in the FDA’s Unique Device Identifier (UDI) database. This registry is mandatory for Class I devices in the U.S. to ensure traceability and compliance with FDA requirements. The UDI system helps track devices throughout their lifecycle, including manufacturing, distribution, and use.

All of PharmChem, Inc.’s listed devices are classified as Class I under U.S. regulations. This classification applies to devices posing minimal risk to patients and users, such as adhesive bandages and certain diagnostic kits. Class I devices typically require general controls like proper labeling and manufacturing practices, but no pre-market approval is needed unless they are modified or present new risks.