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

SteriLance always prioritizes product quality, which is our bottom line and commitment to our customers. We ensure that our products meet health and safety requirements and comply with the regulatory requirements in markets where our products are sold through leading production processes, advanced online image inspection and a TPM quality management system.


■ 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
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Exhibition Plans
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To better serve our friends and understand their needs, we regularly participate in various international medical product trade exhibitions around the globe.
2024 Medi
August 01-03,2024
L8 Booth
Make an appointment
2024 IVDE
July 17-19, 2024
Booth No.: 10.2 Booth B221
Make an appointment
2024 meditech
July 09-12, 2024
Booth No.: 2317G Booth
Make an appointment
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