SteriLance is committed to delivering safe, reliable blood-sampling devices for people with diabetes who monitor glucose at home. All products are manufactured under advanced inline-inspection and TPM systems to meet health-and-safety regulations worldwide.
■ China Medical Device GMP System Certified
■ EN ISO 13485 : 2016 International Medical Device Quality Management System Certified
■ MDSAP Quality System Certified (a medical device audit program participated in by the United States, Canada, Brazil, Australia and Japan)
■ UL 21 CFR Part 820 Medical Device Quality Management System Certified
■ Registered with China NMPA (National Medical Products Administration)
■ U.S. FDA 510(k) Premarket Notification completed
■ MDR EU CE officially certified
■ Medical device registration and certifications in UK, Canada, India and other countries