Got China SFDA Medical Device certificate (Rightest Blood Glucose Meter, Model GM300/GM210). Got China SFDA Medical Device certificate (Rightest Blood Glucose Meter, Model GM300/GM210).
Got Taiwan Medical Device certificate (Rightest Blood Glucose Monitoring System, Model GM100). Got Taiwan Medical Device certificate (Rightest Blood Glucose Monitoring System, Model GM100).
Gradually phase in GD500 for worldwide distributors. Gradually phase in GD500 for worldwide distributors.
Launch GM101 No Coding Blood Glucose Monitoring System with whole blood calibrated reading to Germany. Launch GM101 No Coding Blood Glucose Monitoring System with whole blood calibrated reading to Germany.
Launch GD500 brand new design lancing device with safety switch and lancet eject function to Germany. Launch GD500 brand new design lancing device with safety switch and lancet eject function to Germany.
Introduce GM100 No Coding Blood Glucose Monitoring System to EU market on March, 2008 Introduce GM100 No Coding Blood Glucose Monitoring System to EU market on March, 2008
Got USA FDA 510(k) clearance letter (K072054) (Rightest Blood Glucose Monitoring System, Model GM310 ). Got USA FDA 510(k) clearance letter (K072054) (Rightest Blood Glucose Monitoring System, Model GM310 ).
Set up BIONIME USA branch office in San Diego. Set up BIONIME USA branch office in San Diego.
Renew ISO 13485/CE Certificate Renew ISO 13485/CE Certificate
Renew ISO 13485/CE Certificate Renew ISO 13485/CE Certificate