History

HMD Biomedical Development History and Milestones

2017.9 MDSAP certification approved

2015.3 Signed PDP's with Brazil government

2014.1 GSM Cloudia G2 FDA 510(k) cleared

2013.9 Brazil ANVISA certification approved

2013.2 GenUltra CS-300 FDA 510(k) cleared

2012.11 NS101 POCT FDA 510(k) cleared

2012.7 AC200 FDA 510(k) cleared

2010.9 Cloudia FDA 510(k) cleared

2010.4 Xinpu new factory completed

2010.1 Supply POCT system to OGH

2008.12 China SFDA certification approved

2006.9 US FDA 21CFR-820 QSR certification

2005.8 US CAP certification approved

2005.5 GMP certification approved

2003.5 GlucoLeader Value FDA 510(k) cleared

2003.1 GlucoLeader Enhance FDA 510(k) cleared

2002.9 ISO 9001 and ISO 13485 certified

2002.9 CE certification (MDD 93/42/EC) approved

2000.5 Company founded in Hsinchu, Taiwan

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