Is Dip.io FDA approved or cleared?

Yes. Dip.io by Healthy.io Ltd. is named in the FDA register with a 510(k) clearance, latest decision in 2018.

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

At a glance

Product	Dip.io
Maker	Healthy.io Ltd.
Care area	Other
What it does	Urinalysis testing platform with smartphone-based result interpretation
FDA	510(k), latest decision 2018
Verification level	Exact product named in the FDA record (checked 18 October 2026)
EU (CE)	No CE listing found
Website	healthy.io
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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