About Us -> Quality Commitment
Mindray has always given top priority to product quality and was one of the first medical equipment companies in China to obtain TUV ISO9001/13485 Certification, CE Mark and FDA Clearance.

1995 TÜV Ps ISO 9001, the first one in China’s medical device industry
2000 Quality system certification of CMDC
2000 CE Mark for patient monitoring products
2003 CE Mark for ultrasound imaging systems
2003 CE Mark for clinical laboratory instruments
2004 FDA 510(k) Clearance for patient monitoring products
2005 FDA 510(k) Clearance for ultrasound imaging system
2006 Certified by UL for the Safety Test Lab, the first one in China’s medical device industry
2007 FDA 510(k) Clearance for hematology analyzer
2007 Reliability Test Lab certified by CNAS, the first one in China’s medical device industry
2008 FDA 510(k) Clearance for auto chemistry analyzer
2009 Certified by ETL for the Safety Test Lab
2009 Standardization Lab certified by CNAS, the first one in China’s medical device industry
2011 Reliability Test Lab Accredited as the CB-MTL by UL and Intertek