Is Caresens Air certified as a medical device?
Caresens Air by i-SENS, Inc. is listed in EUDAMED as a CE class IIb medical device. The manufacturer holds a valid notified body certificate under the MDR in EUDAMED. We found no FDA authorisation.
At a glance
| Product | Caresens Air |
|---|---|
| Maker | i-SENS, Inc. |
| Care area | Diabetes & metabolism |
| What it does | Smart glucose monitoring system with data management and sharing capabilities |
| FDA | No FDA authorisation found |
| EU (CE) | Class IIb |
| EU certificate | Manufacturer certificate from a notified body (MDR) in EUDAMED (checked 18 October 2026) |
| Website | i-sens.com |
| Status | CE verified |
| Last checked | 6 October 2026 |
Need the evidence behind this entry?
Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes
Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes
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