Device Dossier
Invasive interstitial-fluid glucose monitoring system
Device Dossier for Invasive interstitial-fluid glucose monitoring system (Invasive interstitial-fluid glucose monitoring system, Class IIb, sponsor Roche…
- GMDN category: Invasive interstitial-fluid glucose monitoring system
Intended purpose
The Accu-Chek SmartGuide continuous glucose monitoring device (CGM device) is intended for continuous measurement of real-time glucose levels in the subcutaneous interstitial fluid. Intended users • Adults, 18 years of age and older • People with diabetes mellitus • Caregivers of people with diabetes mellitus