App icon of Minuteful Kidney, from the App Store

Is Minuteful Kidney FDA approved or cleared?

Yes. Minuteful Kidney by Healthy.io Ltd. is named in the FDA register with a 510(k) clearance, first authorised in 2022, latest decision in 2023.

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

At a glance

Product	Minuteful Kidney
Maker	Healthy.io Ltd.
Care area	Other
What it does	At-home kidney function testing with smartphone-based urinalysis
FDA	510(k), latest decision 2023
Verification level	Exact product named in the FDA record (checked 18 October 2026)
EU (CE)	No CE listing found
Website	healthy.io/eu
Status	FDA verified
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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