Global Regulatory Compliance & Certifications
Global Product Certifications
Your Passport to International Markets: YKD medical accessories hold comprehensive regulatory clearances, ensuring seamless market entry for our distributors in the US, Europe, LATAM, and Asia.
Quality Management Systems (QMS) & Factory Standards
Quality is not just a promise; it is a system. Our manufacturing facilities are audited and certified to the highest international standards.
Intellectual Property: Patents & Trademarks
With over 18+ years of R&D, YKD protects its proprietary technology and design, offering our partners “Freedom to Operate” without legal risks.
Q: Does YKD have FDA clearance for SpO2 sensors?
A: Yes, YKD holds FDA 510(k) clearance for its range of SpO2 sensors and cables.
Q: Is YKD an ISO certified manufacturer?
A: YKD is certified under ISO 13485:2016 and ISO 9001:2015 for the design and manufacturing of medical accessories.
Q: Can YKD issue a Certificate of Free Sale (CFS)?
A: Yes, backed by our NMPA registration, we provide legalized CFS for global tenders.