All apps · Diabetes & metabolism

Is iHealth Gluco-Smart FDA approved or cleared?

Not as such. iHealth Lab holds a 510(k) clearance for related hardware, latest decision in 2019, but iHealth Gluco-Smart itself is not named in the FDA record.

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

At a glance

Product	iHealth Gluco-Smart
Maker	iHealth Lab
Care area	Diabetes & metabolism
What it does	Bluetooth-enabled glucose meter with smartphone app for diabetes management
FDA	510(k), latest decision 2019
Verification level	Related hardware authorised; this app itself is not named (checked 18 October 2026)
EU (CE)	No CE listing found
Website	ihealthlabs.com
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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