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Quality and Product Certifications
Quality and Product Certifications
Quality
Quality and Product Certifications
Quality

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


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Testimonials
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As a global and national leader in the blood glucose meter business, we are proud to collaborate with leading professional manufacturers in China to better serve our diabetic patients. We take great pride in our 10-year partnership with SteriLance Medical, forged through mutual benefit, top-notch product quality, and a strong foundation of trust.
Prominent domestic and international brand blood glucose meter clients
News
Stay updated with the latest news and achievements from SteriLance Medical.
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exhibition
Exhibition Plans
exhibition
To better serve our friends and understand their needs, we regularly participate in various international medical product trade exhibitions around the globe.
2025 91届CMEF
April 08-12, 2025
Booth No.:Hall 7.1 7.1P14
Make an appointment
2025 Expomed Eurasia
April 24-26 2025
Booth No.: Hall 8. 829F
Make an appointment
VIETNAM MEDI —PHARM 2025
May 08-11, 2025
Booth No.: Hall A-90
Make an appointment
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