9月23日 的 Instara-G1 應用程式分析

Instara-G1 – Companion App for Continuous Glucose Monitoring (Requires compatible TX-series CGM device) Instara-G1 is the companion app for the TX-series continuous glucose monitoring (CGM) system. It syncs glucose data from a compatible TX-series device and provides trends, event logging, and report sharing. Regulatory & jurisdiction statement The TX-series CGM system is CE-marked under EU MDR (Class IIb). Medical use of the system (including this app as its companion software) within the European Economic Area (EEA) is authorized for the EU Member States and Iceland, Liechtenstein, and Norway: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Iceland, Liechtenstein, and Norway. The hardware also has applicable national registration or market documentation in the United Kingdom, Switzerland, Türkiye, Pakistan, Indonesia, Mongolia, Hong Kong, Guatemala, Panama, Saudi Arabia, Qatar, Oman, the Dominican Republic, Uganda, and Tanzania. Iceland is additionally covered under EEA CE authorization and has supplemental App Store medical-device declaration documentation. For any jurisdiction not expressly listed above or not covered by your current Pricing & Availability selection, the app is not authorized for medical diagnosis, monitoring, treatment, or clinical decision-making unless and until local authorization applies. Medical disclaimer Always consult a licensed physician or qualified healthcare professional before making any medical decisions (including medication, insulin, diet, or treatment adjustments). Do not rely solely on this app or CGM readings for clinical judgment. If readings do not match how you feel or symptoms, use a finger-stick blood glucose meter as directed by your healthcare provider and seek medical care promptly. Hardware requirement This app does not function as a standalone medical device. A compatible TX-series CGM device is required.