關於保生

Company Milestones

Focus on in vitro diagnostic medical device products related to Point-of-Care Testing (POCT) for chronic diseases

2010- Company founded at the Nangang Biotech Incubation Center

2011- Approved for the Industrial Technology Projects by the Industrial Development Bureau (MOEA)

2011- Obtained ISO 13485:2003 certification for medical device quality management systems

2012- Approved for Leading Project by the Industrial Development Bureau, MOEA

2013- Relocated to Guishan Industrial District, Taoyuan; established own factory and cleanroom facilities

2014- Passed Good Manufacturing Practice (GMP) certification for medical devices by the Ministry of Health and Welfare (MOHW), Taiwan

2017- Passed GMP re-inspection by the MOHW

2018- Received Medical Device Registration Approval (TFDA) from MOHW

2021- Received Medical Device Registration Approval (TFDA) from MOHW

2023- Obtained CE certification

2023- Received US FDA approval

2024- Received Medical Device Registration Approval (TFDA) from MOHW

Awards & Recognitions Over the Years

2012- Winner of the 9th National Brand Yushan Award – Best Product Category

2012- AmiShield Veterinary Clinical Analyzer received the SNQ (Symbol of National Quality) Certification

2012- Honored as an Elite Enterprise in the Incubator Accelerator Program, awarded the Excellence in Incubation Acceleration Award

2018- ENNOLIFE Clinical Chemistry Analyzer awarded the 27th Taiwan Excellence Award

2020- Winner of the 1st Taoyuan Regional Outstanding Brand – International Export Potential Award

2020- ENNOLIFE Clinical Chemistry Analyzer received the SNQ (Symbol of National Quality) Certification 

COVID-19 Response- ENNOLIFE COVID-19 Antigen Rapid Test Kit obtained Emergency Use Authorization (EUA) from TFDA (Taiwan Food and Drug Administration) for pandemic prevention