Awards and Recognition
The RIGHTEST iFree CGM has been approval from Taiwan’s Ministry of Health and Welfare Food and Drug Administration (TFDA) for a Class II medical device sales license, making it the first manufacturer in Taiwan to receive certification for CGM products.
Corporate Milestones
2003
──
2025
Corporate Milestones─2003 ── 2025
．
In January, the ISO/IEC 27017:2015 Cloud Services Information Security Management and the ISO/IEC 27018:2019 Protection of Personal Data in Public Cloud Services were obtained.
．
In November, the RIGHTEST iFree CGM Continuous Glucose Monitoring System was awarded the 2025 TaiwanExcellence Gold Award.
．
In October, the RIGHTEST iFree CGM Product Launch Event was held with the theme of Care-Driven Forward.
．
In September, the RIGHTEST iFree CGM Continuous Glucose Monitoring System was awarded the Taipei Biotech Innovation Technology Gold Award.
．
In June, the ISO 14064-1 Greenhouse Gas Management System Certification was obtained.
．
In January, the ISO 27001:2022 Information Security Standard Certification and the ISO/IEC 27701:2019 Privacy Information Management System Certification were obtained.
．
In November, the ISO 45001:2018 Occupational Health and Safety Management System Certification was obtained.
．
In October, RIGHTEST iFree CGM Obtained the sales license for Class II medical devices approved by the Taiwan Food and Drug Administration (TFDA), becoming the first manufacturer in Taiwan to receive CGM product certification.
．
In September, the new product CGM Continuous Glucose Monitor obtained the TFDA registration for CGM product inspection.
．
In September, the QMS Medical Device Quality Management System Certificate was obtained.
．
In July, the RIGHTEST Partner App was launched, allowing real-time sharing of blood glucose data with family and friends, creating a personalized remote care circle.
．
In May, the GM700 Pro2 Blood Glucose Monitoring System was launched, integrating both in-hospital and out-of-hospital information to initiate comprehensive management.
．
In March, the ISO/IEC 27701:2019 Privacy Information Management System Certification was obtained.
．
In March, the RIGHTEST CARE App blood glucose management application obtained CE certification.
．
In January, the MDSAP Medical Device Single Audit Program certificate was obtained.
．
In November, the RIGHTEST Precision Health Co-Care Circle won the 2020 28th Taiwan Excellence Award.
．
In November, the RIGHTEST Comprehensive Smart Blood Glucose Management Service won the 2019 27th Taiwan Excellence Award.
．
In March, the subsidiary BIONIME (Malaysia) SDN BHD was established in Malaysia.
．
In February, the ISO 27001:2013 Information Security Standard Certification was obtained.
．
In October, the latest version of the ISO 13485:2016 Medical Device Quality Management System Certification was obtained.
．
In July, the RIGHTEST CARE App blood glucose management application was launched and officially listed on Google Play and the App Store.
．
In July, the GM700SB RIGHTEST Blood Glucose Monitoring System with Bluetooth functionality was first launched in the Taiwan market.
．
In June, the new RIGHTEST brand identity was launched.
．
In February, the GM700 Pro Smart Remote Blood Glucose Care Platform won the 2017 25th Taiwan Excellence Award.
．
In August, the ANVISA Quality System Certification issued by the Brazilian Health Regulatory Agency was obtained.
．
In April, the GMP Medical Device Good Manufacturing Practice Certification was obtained for 9 related items,1including the newly added uric acid meter and cholesterol meter.
．
In December, the private placement was completed, bringing in the strategic investor Tonghua Dongbao.
．
In April, the China Utility Model Patent for the Insulin Measuring Pen with Attached Biosensor was obtained.
．
In January, the Pingtan subsidiary was established, and the GE333 Bluetooth Blood Glucose Meter was launched in the China market.
．
In November, the GM722 Blood Glucose Monitoring System won the Silver Medal of the 103rd National Invention and Creation Award.
．
In June, a delegation of diplomatic and business personnel stationed in China visited Bionime for business exchanges.
．
In January, the GM720 Blood Glucose Monitoring System won the 2014 Taiwan Excellence Award.
．
In October, the GM720 New Blood Glucose Meter was honored with the Ministry of Economic Affairs Industry
Innovation Achievement Award.
．
In September, the GD500 Lancing Device won the Silver Medal of the National Invention Award.
．
In September, Bionime’s new Daqing plant passed the Taiwan GMP Medical Device Good Manufacturing Practice Certification.
．
In March, the mylife Unio Blood Glucose Monitoring System won the German Red Dot Design Award.
．
In March, Bionime’s new office building at the Daqing plant in Taichung was completed.
．
In December, the new product Unio was shipped to Europe.
．
In January, GE Group from the United States selected Bionime to officially launch the GE-branded blood glucose meter.
．
In December, Bionime was awarded the Ministry of Economic Affairs National Industry Innovation Award for
Excellence in the Innovation Organization category.
．
In September, Bionime passed the OHSAS Occupational Health and Safety Management System Certification.
．
In July, land was purchased in preparation for the expansion of the company’s own factory and office building.
．
In July, the AEO certification was obtained, recognizing the company as a high-quality enterprise for safety
verification in the import and export industry as well as manufacturing.
．
In March, a brand licensing agreement was signed with GE.
．
In December, the company completed a cash capital increase and was listed on the stock exchange with the stock code 4737.
．
In September, the company was approved by the Industrial Development Bureau of the Ministry of Economic
Affairs to apply for listing as a technology enterprise.
．
In August, the product won the highest award, the Technology Commercialization Gold Award, at the Taipei
BioIndustry Award.
．
In February, the Bionime Australia Pty Ltd. subsidiary was established in Australia.
．
In July, the RIGHTEST GM100/110 Blood Glucose Monitoring System series passed the China SFDA product certification.
．
In May, the RIGHTEST GM500 Blood Glucose Monitoring System was officially launched.
．
In April, the KGMP Quality System Certification was obtained.
．
In January, the company was listed on the Taiwan OTC market with the company code 4737.
．
In October, a strategic alliance was formed with Ypsomed, the leading brand of diabetes injection systems
from Switzerland.
．
In September, the RIGHTEST GM100/110 Blood Glucose Monitoring System obtained the FDA 510(K) clearance.
．
In March, the RIGHTEST GD500 Lancing Device was officially launched.
．
In February, the U.S. subsidiary was established.
．
In August, the ISO 13485 Quality Management System Certification and CMDCAS audit were successfully passed.
．
In July, the TNO product system certification was obtained.
．
In March, the RIGHTEST GM100 Blood Glucose Monitoring System was officially launched.
．
In March, the RIGHTEST GM100 Blood Glucose Monitoring System was officially launched.
．
In August, the RIGHTEST GM300 Blood Glucose Monitoring System passed the SFDA product certification in China.
．
In June, it passed the Taiwan GMP quality system certification.
．
In May, the RIGHTEST GM300 Blood Glucose Monitoring System was officially launched.
．
In April, the RIGHTEST Swiss subsidiary was established.
．
In January, the RIGHTEST GM300 Blood Glucose Monitoring System obtained FDA 510(k) clearance.
．
In December, Bionime was registered and established as a company.
．
In November, obtained CE certification and passed ISO 13485 quality management system certification.
．
In October, the first-generation blood glucose monitoring system was successfully developed.
．
In April, Bionime was established in Dali, Taichung.
Bionime Corporation │ Customer Service Hotline 0800-371-688 │ Service Hours: Monday to Friday 8:30-22:00
Awards and Recognition
The RIGHTEST iFree CGM has been approval from Taiwan’s Ministry of Health and Welfare Food and Drug Administration (TFDA) for a Class II medical device sales license, making it the first manufacturer in Taiwan to receive certification for CGM products.
Corporate Milestones
2003 ─ 2025
．
In January, the ISO/IEC 27017:2015 Cloud Services Information Security Management and the ISO/IEC 27018:2019 Protection of Personal Data in Public Cloud Services were obtained.
．
．
．
．
．
In November, the RIGHTEST iFree CGM was awarded the 2025 Taiwan Excellemce Gold Award.
In October, the RIGHTEST iFree CGM Product Launch Event was held with the theme of Care-Driven Forward.
In September, the RIGHTEST iFree CGM was awarded the Taipei Biotech Innovation Technology Gold Award.
In June, the ISO 14064-1 Greenhouse Gas Management System Certification was obtained.
In January, the ISO 27001:2022 Information Security Standard Certification and the ISO/IEC 27701:2019 Privacy Information Management System Certification were obtained.
．
．
In November, the ISO 45001:2018 Occupational Health and Safety Management System Certification was obtained.
In October, RIGHTEST iFree CGM obtained the Class II medical device sales license from Taiwan’s Food and
Drug Administration (TFDA), becoming the first manufacturer in Taiwan to receive CGM product certification.
．
．
In September, the new CGM product obtained the TFDA registration for CGM.
In September, the QMS Medical Device Quality Management System Certificate was obtained.
．
．
．
In July, the RIGHTEST partner App was launched, allowing real-time sharing of blood glucose data with
family and friends, creating a personalized remote care circle.
In May, the GM700 Pro2 Blood Glucose Monitoring System was launched, integrating both in-hospital and out-
of-hospital information to initiate comprehensive management.
In March, the ISO/IEC 27701:2019 Privacy Information Management System Certification was obtained.
．
．
In March, the RIGHTEST CARE App blood glucose management application obtained CE certification.
In January, the MDSAP Medical Device Single Audit Program certificate was obtained.
．
In November, the RIGHTEST Precision Health Co-Care Circle won the 2020 28th Taiwan Excellence Award.
．
．
．
In November, the RIGHTEST Comprehensive Smart Blood Glucose Management Service won the 2019 27th
Taiwan Excellence Award.
In March, the subsidiary BIONIME (Malaysia) SDN BHD was established in Malaysia.
In February, the ISO 27001:2013 Information Security Standard Certification was obtained.
．
．
．
．
．
In October, the latest version of the ISO 13485:2016 Medical Device Quality Management System Certification was obtained.
In July, the RIGHTEST CARE App blood glucose management application was launched and officially available on Google Play and the App Store.
In July, the GM700SB RIGHTEST Blood Glucose Monitoring System with Bluetooth functionality was first launched in the Taiwan market.
In June, the new RIGHTEST brand identity was launched.
In February, the GM700 Pro Smart Remote Blood Glucose Care Platform won the 2017 25th Taiwan Excellence Award.
．
．
In August, the ANVISA Quality System Certification issued by the Brazilian Health Regulatory Agency was obtained.
In April, the GMP Medical Device Good Manufacturing Practice Certification was obtained for 9 related items,
including the newly added uric acid meter and cholesterol meter.
．
．
．
In December, the private placement was completed, bringing in the strategic investor Tonghua Dongbao
Pharmaceutical Co.,Ltd.
In April, the China Utility Model Patent for the Insulin Measuring Pen with Attached Biosensor was obtained.
In January, the Pingtan subsidiary was established, and the GE333 Bluetooth Blood Glucose Meter was launched in the China market.
．
．
．
．
In December, the Analyte Measurement Device was granted a German Utility Model Patent.
In November, the GM722 Blood Glucose Monitoring System won the Silver Medal of the 103rd National Invention and Creation Award.
In June, a delegation of diplomatic and commercial representatives stationed in China visited Bionime for business exchanges.
In January, the GM720 Blood Glucose Monitoring System won the 2014 Taiwan Excellence Award.
．
．
．
．
．
In October, the GM720 New Blood Glucose Meter was recognized with the Ministry of Economic Affairs Industry Innovation Achievement Award.
In September, the GD500 Lancing Device won the Silver Medal of the National Invention Award.
In September, Bionime’s new Daqing plant passed the Taiwan GMP Medical Device Good Manufacturing Practice Certification.
In March, the mylife Unio Blood Glucose Monitoring System won the German Red Dot Design Award.
In March, Bionime’s new plant office building at the Daqing plant in Taichung was completed.
．
．
In December, the new product Unio was shipped to Europe.
In January, GE Group from the United States selected Bionime to officially launch the GE-branded blood glucose meter.
．
．
．
．
．
In December, Bionime was awarded the Ministry of Economic Affairs National Industry Innovation Award for Excellence in the Innovation Organization category.
In September, Bionime passed the OHSAS Occupational Health and Safety Management System Certification.
In July, land was purchased in preparation for the expansion of the company-owned factory and office building.
In July, the AEO certification was obtained, recognizing the company as a high-quality enterprise for safety verification in the import and export industry as well as manufacturing.
In March, a brand licensing agreement was signed with GE.
．
．
．
．
In December, the company completed a cash capital increase and was listed on the stock exchange under the stock ticker symbol 4737.
In September, the company was approved by the Industrial Development Bureau of the Ministry of Economic Affairs to apply for listing as a technology enterprise.
In August, the product won the highest award, the Technology Commercialization Gold Award, at the Taipei Biotech Awards.
In February, the Bionime Australia Pty Ltd. subsidiary was established in Australia.
．
．
．
．
In July, the RIGHTEST GM100/110 Blood Glucose Monitoring System series passed the China SFDA product certification.
In May, the RIGHTEST GM500 Blood Glucose Monitoring System was officially launched.
In April, the KGMP Quality System Certification was obtained.
In January, the company was listed on the Taiwan Over-the-Counter (OTC) market with the company code 4737.
．
．
．
．
In October, a strategic alliance was formed with Ypsomed, a leading Swiss brand of diabetes injection
systems.
In September, the RIGHTEST GM100/110 Blood Glucose Monitoring System obtained the FDA 510(K) clearance.
In March, the RIGHTEST GD500 Lancing Device was officially launched.
In February, the U.S. subsidiary was established.
．
．
．
In August, the ISO 13485 Quality Management System Certification and CMDCAS audit were obtained.
In July, the TNO product system certification was obtained.
In March, the RIGHTEST GM100 Blood Glucose Monitoring System was officially launched.
．
In February, the Shenzhen subsidiary was established.
．
．
．
．
．
In August, the RIGHTEST GM300 Blood Glucose Monitoring System passed the SFDA product certification in China.
In June, it passed the Taiwan GMP quality system certification.
In May, the RIGHTEST GM300 Blood Glucose Monitoring System was officially launched.
In April, the RIGHTEST Swiss subsidiary was established.
In January, the RIGHTEST GM300 Blood Glucose Monitoring System obtained FDA 510(k) clearance.
．
．
In December, Bionime was officially registered and incorporated as a company.
In November, obtained CE certification and passed ISO 13485 quality management system certification.
．
．
In October, the first-generation blood glucose monitoring system was successfully developed.
In April, Bionime was established in Dali, Taichung.
