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Mindray has always given top priority to product quality and was among the first medical equipment companies in China to obtain TUV ISO9001/13485 Certification, CE mark and FDA approval.
1995 China's first medical device enterprise to obtain ISO9001/EN46001 Quality Assurance Certification from TUV, Germany
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 China's first medical device manufacturer to be certified by UL for the Safety Test Lab
2007 FDA 510(K) clearance for Hematology Analyzer
2008 FDA 510(K) clearance for Biochemistry Analyzer |