We are committed to international quality and compliance. Our certifications demonstrate our dedication to
excellence, safety, and reliability in manufacturing.
All these certifications ensure that our products can be exported and freely sold in European and U.S. markets, without any trouble in customs clearance or registration with your country's health authorities.
European MDR CE Certificate — issued by TÜV SÜD ISO 13485 Quality Management System — certified by TÜV SÜD Free Sale Certificate for Medical Device Exporting — issued by SFDA FDA Registration — registered since 2006 with the U.S. Food and Drug Administration Join the Global Network of Trusted Ortho Partners !
