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Is NichtraucherHelden-App certified as a medical device?

NichtraucherHelden-App by Sanero Medical 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

Product	NichtraucherHelden-App
Maker	Sanero Medical GmbH
Care area	Mental health
What it does	Digital smoking cessation programme for tobacco dependence
FDA	No FDA authorisation found
EU (CE)	Class I (self-declared)
German DiGA	permanent
Website	nichtraucherhelden.de/medizinprogramm.jsf
Status	EU DiGA
Last checked	6 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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