THT BIO-SCIENCE

THT Bio-Science specializes in surgical mesh products. Their portfolio includes devices like the RECTO-SWING®, designed for rectal procedures, and multiple variants of SWING-MESH®, which are intended for hernia repair and pelvic floor reinforcement. They also produce the SWING-SYSTEM® RU for specific surgical applications, INTRA-SWING® for internal fixation, and SWING-CONTACT®, likely tailored for precise tissue contact in surgical settings. These devices are used in both minimally invasive and open surgical procedures.

THT Bio-Science is based in France, which places their devices under the jurisdiction of the European Union’s Medical Device Regulations (MDR). As an EU-based manufacturer, their products must comply with EU regulatory standards, including mandatory registration in the eudamed database. This ensures traceability and adherence to EU requirements for medical devices, aligning their operations with the regulatory framework governing medical devices in the EU market.

THT Bio-Science’s devices are listed in the eudamed database, which is the official EU registry for medical devices under the MDR. Listing in eudamed is critical because it ensures transparency, traceability, and compliance with EU regulatory requirements. It allows healthcare professionals, authorities, and patients to verify the legitimacy of the devices and their manufacturer, while also facilitating market surveillance and post-market monitoring.

THT Bio-Science’s devices are classified as Class I and Class IIb under EU regulations. Classification determines the level of regulatory scrutiny and risk associated with a device. Class I devices generally pose the lowest risk and require basic conformity assessments, while Class IIb devices involve higher risks (such as those related to surgical meshes) and require more rigorous pre-market evaluations, including clinical data and conformity assessments by a Notified Body. This classification ensures appropriate oversight based on the device’s intended use and potential risks.