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Is Kranus Mictera certified as a medical device?

Kranus Mictera by Kranus Health GmbH is listed in the German DiGA directory of reimbursed digital health apps (status: permanent), CE class I. We found no FDA authorisation.

At a glance

ProductKranus Mictera
MakerKranus Health GmbH
Care areaOther
What it doesDigital therapy for stress and urge urinary incontinence
FDANo FDA authorisation found
EU (CE)Class I (self-declared)
German DiGApermanent
Websitekranushealth.com/de/therapien/inkontinenz
StatusEU DiGA
Last checked6 October 2026

Certification status can change. Always confirm in the official register before relying on it: the FDA databases, EUDAMED or the BfArM DiGA directory.

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