CELLMEDIX HOLDINGS, LLC

CellMedix Holdings, LLC specializes in manufacturing kits used for preparing haematological concentrates, specifically platelet concentrates. Their primary products include phlebotomy kits for blood collection and platelet concentration kits, such as the ProGen PC Kit and Centripid PC. These devices are designed to assist in the collection and processing of blood components for medical use.

CellMedix Holdings, LLC is based in the United States. The company’s location is relevant for understanding regulatory oversight, as it operates under the jurisdiction of the U.S. Food and Drug Administration (FDA).

CellMedix Holdings, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices commercially distributed in the U.S., ensuring traceability and compliance with regulatory requirements.

CellMedix Holdings, LLC’s devices are classified as Class II under FDA regulations. This classification applies to devices that generally pose moderate risk and require special controls to ensure their safety and effectiveness, such as platelet concentration kits and phlebotomy kits.