Is INKA certified as a medical device?
INKA by NEXTEC Medical GmbH is listed in the German DiGA directory of reimbursed digital health apps (status: provisional), CE class I. We found no FDA authorisation.
At a glance
| Product | INKA |
|---|---|
| Maker | NEXTEC Medical GmbH |
| Care area | Other |
| What it does | Digital therapy for overactive bladder and urge incontinence |
| FDA | No FDA authorisation found |
| EU (CE) | Class I (self-declared) |
| German DiGA | provisional |
| Website | meine-inka.de |
| Status | EU DiGA |
| Last checked | 6 October 2026 |
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