Is Navina Smart App certified as a medical device?
Navina Smart App by Wellspect HealthCare is listed as a CE class I medical device. Class I is self-declared by the maker, without review by a notified body. We found no FDA authorisation.
At a glance
| Product | Navina Smart App |
|---|---|
| Maker | Wellspect HealthCare |
| Care area | Other |
| What it does | App for the Navina Smart transanal irrigation system for bowel management |
| FDA | No FDA authorisation found |
| EU (CE) | Class I (self-declared) |
| Website | wellspect.com |
| Status | CE class I |
| Last checked | 7 October 2026 |
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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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