五鼎生物技術 ApexBio Taiwan

History


2018	KET-1 FDA 510K approval


2017	Pass Brazil ANVISA on-site audit
	3rd time AEO certified by Customs Admin. Acquired Omnis Health LLC.


2016	Apr. - Passed 4th FDA on-site inspection
	Dec. - FDA510(k) approval of the BGM014 Blood Glucose Monitoring System.


2015	Oct. - Outstanding Category Awards of APEA 2015 ( Asia Pacific Entrepreneurship Awards )



2014	Dec. - Authorized Economic Operator (AEO) by Customs Admin, Ministry of Finance



2013	Feb. - 1st Taiwan MITTELSTAND Award from the MOEA
	Feb. -「The rejection strip holder for AutoSure meter」US patent gained. May. - Taoyuan Wuqing facility start mass production.


2012	Jan. - FDA approval of「CAL-1A」
	Apr. - FDA approval of「MEG-2B」. Jul. - FDA approval of「Cap for waterproof container」. Aug. - The first Unsecured Convertible Bond issued. Aug. -「Composite modified electrode strip」US patent gained. Aug. - The fourth time awarded by Forbes Asia as “200 Best under a Billion”. Aug. - Apex Biotechnology (Suzhou) Corporation starts to operation in China. Sep. - Capital increased to 98,531,420 shares. Nov. - Purchasing a new facility (Wuqing factory in Taoyuan). Dec. -「Filled detection for metal electrode test strip」US patent gained.


2011	Apr. - FDA approval of AutoSure Voice 3 system
	Sep. - FDA approval of the Gal-1C Blood Glucose Monitoring System. Dec. - 1.Innovation Product Awards - Eclipse A1c Hemoglobin HbA1c measuring system. 2.Passed AEO (Authorized Economic Operator) Certification by Taipei Customs Office.


2010	Jan. - Local ERP system changed into Oracle JDE
	Jul. - Selected by CommonWealth Magazine as one of the "Taiwan's Fast Growth Enterprise 50". Oct. - Implement Agile - PLM system (Product life cycle management).


2009	Mar. - to be selected Taiwan A+ Entrepreneur by Global Views
	Monthly the average ROE 24.78% within 5 years, 20.97% within 10 years.


2008	Mar. - FDA 510 (k) approval of the GlucoSure Voice Blood Glucose Monitoring System
	Approval number K073137. Oct. - Awarded by Forbes Asia as “200 Best under a Billion” three years in a row. Nov. - A1c Xpress POC HbA1c and Hemoglobin Analyzer awarded as “Innovative Product of the Year” at Taipei Mediphar Trade Show.


2007	Oct. - Awarded by Forbes Asia as "200 Best under a billion"
	June - Awarded by Frost & Sullivan as "Healthcare Award for Upcoming Medical Device Company of the year".


2006	Oct. - Awarded by Forbes Asia as "200 Best under a billion"
	April - Passed 2nd FDA on-site inspection. March - HsinChu Li-Hsin new facility start to operate.


2005	July - Move-in New Facility



2004	Aug. - Co-Development of Bioluminescence Microsystems with ITRI



2003	Nov. - Purchasing of a new facility (23,867 M2)



2002	May - MultiSure Glucose & Uric Acid System Product Launch
	June - Move-in new factory site (6,600 M2) Sep. - 1.MultiSure Glucose & Uric Acid System - Industrial Technology Advancement award from the MOEA Dec. 2.HbA1c Project - Subsidy granted from IDB. Dec. - Small business innovation research award from the MOEA.


2001	Sept. - Listed on the Taiwan Stock Exchange (stock code 1733)
	Aug. - Passed 1st FDA on-site inspection


2000	June - Listed on the Taiwan Over-The-Counter Securities Exchange



1999	April - GlucoSure Blood Glucose Monitoring System launch



1998	Nov. - Sensorex Blood Monitoring System wom "Product of the year" on Mediphar, Taipei



1997	Dec. - ApexBio founded in HsinChu Science Park



1996	June - Sensores system won "Gold National Award of Excellence"

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