All apps · Diabetes & metabolism

Is GlucoMe certified as a medical device?

We could not confirm the certification that GlucoMe claims in the FDA register, EUDAMED or the German DiGA directory. It is on our public watchlist until the maker provides a reference number we can verify.

In the EU: no CE listing found in EUDAMED. Not every CE-marked device is registered there yet.

At a glance

Product	GlucoMe
Maker	GlucoMe Ltd.
Care area	Diabetes & metabolism
What it does	Connected blood glucose monitoring system with AI-powered insights
FDA	No FDA authorisation found
EU (CE)	No CE listing found
Website	glucome.com
Status	Watchlist
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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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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