2025
Obtained SFDA (Saudi Arabia) and TITCK (Turkey) certifications
2024
Obtained EU MDR Certificate
2022
Obtained the MDSAP certification, recognized by Australia TGA, Brazil ANVISA, Health Canada, USA FDA, MHLW/PMDA
2020
Obtained Dun & Bradstreet D-U-N-S® Registered™ certification
2019
Passed MDSAP audit, recognized by the U.S.FDA and Health Canada
2017
MDSAP Project Launched
Signed Academic Research Agreement with Shenzhen University
2016
Acquisition by Xinhai Group
2014
Acquisition of TMC Medical
2012
Awarded National High-tech Enterprise
2010
Xinhai Group Acquired 20% Shareholding
2008
FDA 510(K) Clearance
2006
CE Certification Attended MEDICA, Germany for the First Time Passed ISO 13485 QMS Certification
2005
Obtained ISO13485 System Certification
2004
Established in Shekou, Shenzhen
