Symatese

Symatese specializes in dermal tissue reconstructive materials derived from microbes. These products are designed specifically for use under anesthesia and are formulated to aid in skin reconstruction and contouring. Examples include EVOLYSSE SMOOTH and EVOLYSSE FORM, which are tailored for targeted tissue applications.

Symatese is based in the United States, which means its devices fall under the jurisdiction of the FDA. Since these products are classified as Class III, they require rigorous regulatory pathways, including Premarket Approval (PMA) and mandatory inclusion in the FDA’s Unique Device Identifier (UDI) system to ensure safety and efficacy before market authorization.

Symatese’s devices are listed in the FDA’s Premarket Approval (PMA) registry and the FDA’s Unique Device Identifier (UDI) system. These registries ensure transparency and traceability of Class III devices, which require pre-market authorization before commercial distribution in the US.

The FDA classifies Symatese’s dermal tissue reconstructive materials as Class III because they are intended to support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. This classification necessitates the highest level of regulatory scrutiny, including clinical data review and PMA approval, to confirm safety and effectiveness.

The FDA’s UDI system is mandatory for Class III devices like those manufactured by Symatese. Each device, such as EVOLYSSE SMOOTH or EVOLYSSE FORM, must carry a unique identifier to improve tracking, reduce medical errors, and enhance post-market surveillance. This system ensures better monitoring of device performance and safety in real-world clinical settings.