About
HMD
Devoted in the manufacturing research and development of blood glucose monitoring system, HMD BioMedical is dedicated to provide safe and reliable products to help diabetes families lead a better life and improve the service quality of medical care professionals.
▌Vision
Be the leading company of diabetes cares supplies
▌Mission
Heartiness for Managing Diabetes
▌Professional
Over 30 years in the glucose biosensor research
▌Quality Assurance Policy
▌Response to customer’s claims postively
▌Keep improving product & service quality actively
▌Dedicate in research & development
▌Create the company value via Innovation
About Brand
GlucoLeader ™
As a leading blood glucose tests system company with international patents 40+ since year 2000.
30 years ago ,the founder Dr.Tim Hsu dedicated on the research and development in the portable blood glucose testing technology due to his family was suffering in diabetic foot amputation without a proper and easier way to monitor the blood glucose level at home.
Dr.Tim Hsu teamed up the national project of blood glucose monitoring and production technology as project leader while worked in Industrial Technology Research Institute of Taiwan, R.O.C. and founded HMD Biomedical with the brand of “GlucoLeader” while the related patents were granted.
Product Certificates
Quality System Certificates, MDSAP
Quality System Certificates, EN ISO 13485:2016
Quality System certificate, QMS Republic of China
CE Product Certificates,
98/79/EC on IVDD
History:
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2017.9 - MDSAP Certified
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2015.3 - Signed Parcerias de Desenvolvimento de Produtos (PDP's) with Brazil government
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2014.1 - GSM Cloudia G2 FDA510(k) cleared
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2013.9 - Brazil ANVISA certified
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2013.2 - GoodLife CS-200 FDA510(k) cleared
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2012.11 - NS101 POCT FDA510(k) cleared
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2012.9 - Cloudia FDA510(k) cleared
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2012.7 - AC300 FDA510(k) cleared
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2010.4 - Move-in new factory, Xinpu,Hsinchu
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2010.1 - Supply POCT system and strip to CGH
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2008.12 - SFDA certified
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2005.9 - US CAP certified
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2005.9 - FDA 21CFR.820 QSR
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2005.5 - GMP certified
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2003.5 - GlucoLeader Value FDA510(k) cleared
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2003.1 - GlucoLeader Enhance FDA510(k) cleared
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2002.9 - IVDD 98/79/EC certified
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2002.9 - ISO9001 & ISO13485 certified
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2000.5 - Founded in Hsinchu,Taiwan
Vision
Be the leading company of diabetes cares supplies
Mission
Heartiness for Managing Diabetes