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App icon of Hailie Smartinhaler, from the App Store

Is Hailie Smartinhaler FDA approved or cleared?

Yes. Hailie Smartinhaler by Adherium (NZ) Ltd. is named in the FDA register with a 510(k) clearance, first authorised in 2018, 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	Hailie Smartinhaler
Maker	Adherium (NZ) Ltd.
Care area	Sleep & breathing
What it does	Smart inhaler sensor system that tracks medication use for asthma and COPD patients, providing real-time feedback via mobile app
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	hailie.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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