Diabetes Sentry Products, LLC
Country not established
- Devices
- 1
What Diabetes Sentry Products, LLC makes
Diabetes Sentry Products, LLC manufactures SLEEP SENTRY™, a medical device designed for monitoring and managing sleep-related conditions in patients with diabetes. The device is intended to track physiological parameters during sleep to help assess glucose trends and potential hypoglycemic events.
The company’s portfolio is regulated under Class III designation in the United States, requiring Premarket Approval (PMA) through the FDA. SLEEP SENTRY™ is listed under the FDA’s PMA registry, reflecting its status as a high-risk device requiring stringent pre-market evaluation.
Catalogue
Sleep Sentry(Tm) Ref P810044
Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Diabetes Sentry Products, LLC have in the registry?
The registry currently lists 1 device for Diabetes Sentry Products, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Diabetes Sentry Products, LLC's devices?
Among its 1 most recently registered device, Diabetes Sentry Products, LLC has devices listed in FDA PMA (1 device).
What risk classes do Diabetes Sentry Products, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Diabetes Sentry Products, LLC's devices are Class III. Each device page shows its own class and authorisation.
What are the newest devices from Diabetes Sentry Products, LLC in the registry?
The most recently registered devices listed for Diabetes Sentry Products, LLC include SLEEP SENTRY(TM).