CARNAMEDICA SP Z O O

Carnamedica Sp. z o.o. specializes in preservation solutions for donor organs, tissues, and cells. Their primary focus is on lung preservation, with a device called LungProtect® designed to maintain lung viability during transport and storage. These solutions are not standalone devices but rather substances used in conjunction with organs or tissues to extend their usability.

Carnamedica Sp. z o.o. is based in the United States. While the company name includes a Polish legal structure (Sp. z o.o.), its operational headquarters and regulatory presence are located in the US.

Carnamedica Sp. z o.o.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices that have been authorized for sale in the US, ensuring traceability and compliance with regulatory requirements.

Carnamedica Sp. z o.o.’s preservation solutions, including LungProtect®, are classified as Class II medical devices. This classification is determined by the FDA based on the level of risk associated with the device. Class II devices generally require special controls in addition to general controls to ensure their safety and effectiveness, such as performance standards or post-market surveillance.