Device Dossier
Sunrise - Sleep disorder interpretive software, professional-use
Device Dossier for Sunrise - Sleep disorder interpretive software, professional-use (Sleep disorder interpretive software, professional-use, Class IIa,…
- GMDN category: Sleep disorder interpretive software, professional-use
Intended purpose
The medical device is an aid for the detection of sleep-related breathing disorders, insomnia disorder, sleep/wake rhythm disorder, hypersomnia disorder, insufficient sleep syndrome and bruxism in adults (above 18 yrs old) with suspicions of sleep disorders. This device is an aid for the detection of sleep-related breathing disorders in children (from 3 to 18 yrs old) with suspicions of obstructive sleep apnea or habitual snoring. It’s also intended to assist healthcare professionals in their diagnosis and prescription decision making, or in referral to further diagnostic assessment when required.