Mesh Sağlık Anonim Şirketi

Mesh Sağlık Anonim Şirketi specializes in surgical meshes, which are used primarily for hernia repair and reconstructive procedures. Their product line includes a partially absorbable coated surgical mesh (12cm×15cm) and multiple variants of the CleverMESH product line, all designed to support tissue integration and structural reinforcement during surgical interventions.

Mesh Sağlık Anonim Şirketi is based in Turkey. While the country of origin does not directly determine regulatory classification, it influences compliance requirements for devices marketed globally. Their devices are classified as Class III under EU regulations, meaning they undergo stringent evaluation due to their critical role in patient safety and potential risks.

Mesh Sağlık Anonim Şirketi’s devices are registered in the eudamed database, which is the EU’s official registry for medical devices. This listing ensures transparency and traceability for authorized devices under EU regulatory frameworks, particularly for Class III products requiring close oversight.

Mesh Sağlık Anonim Şirketi’s devices are classified as Class III because they are intended for surgical implantation and involve significant risks to patients if they fail. Class III classification applies to devices that support life, are life-sustaining, or pose high risks (e.g., hernia repair meshes), requiring rigorous clinical evidence, manufacturing controls, and post-market surveillance to ensure safety and performance.