All apps · Women's health & fertility

App icon of OvuSense, from the App Store

Is OvuSense FDA approved or cleared?

Yes. OvuSense by Fertility Focus Ltd. is named in the FDA register with a 510(k) clearance, latest decision in 2013.

In the EU: CE class IIa, found in EUDAMED. A notified body certificate is linked to the device record in EUDAMED.

At a glance

Product	OvuSense
Maker	Fertility Focus Ltd.
Care area	Women's health & fertility
What it does	Advanced fertility tracking system with continuous temperature monitoring
FDA	510(k), latest decision 2013
Verification level	Exact product named in the FDA record (checked 18 October 2026)
EU (CE)	Class IIa
EU certificate	Linked to the device record in EUDAMED (checked 18 October 2026)
Website	ovusense.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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