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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
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