Accreditation & Compliance
SilSecure USA is committed to the highest standards of safety, quality, and regulatory compliance. Our products meet rigorous international standards and certifications.
FDA Class I Device
Manufactured and marketed in accordance with applicable U.S. medical device requirements
Classification:Class I Medical Device
Risk Level:Low Risk
Regulatory Status:Listed with FDA
CE Marked
CE marked for use within the European Union and EEA countries
Standard:EU Medical Device Regulation (MDR) 2017/745
Regulatory Status:CE Marked
Territory:EU & EEA
ISO 13485 Quality System
Manufactured under an ISO 13485-certified quality management system
ISO Standard:ISO 13485
Focus:Medical Device Quality Management
Scope:Design, Production, and Service
Commitment to Excellence
Our accreditations and certifications reflect our dedication to providing high-quality medical dressings designed to meet rigorous international standards. Every product undergoes testing and quality assurance processes consistent with applicable regulatory requirements.