All apps · Women's health & fertility

Is Sense4baby FDA approved or cleared?

Yes. Sense4baby by AirStrip Technologies is named in the FDA register with a 510(k) clearance, latest decision in 2015.

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

At a glance

Product	Sense4baby
Maker	AirStrip Technologies
Care area	Women's health & fertility
What it does	Fetal monitoring system for pregnancy wellness and baby health tracking
FDA	510(k), latest decision 2015
Verification level	Exact product named in the FDA record (checked 18 October 2026)
EU (CE)	No CE listing found
Website	advancedmaternityinnovations.com/products/sense4baby
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.

Need the evidence behind this entry?
Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes

Other apps in Women's health & fertility

AirStrip OB FDA verified
Ava fertility tracker FDA verified
Clue Birth Control FDA verified
Daye Diagnostic Tampon FDA verified
FD200 Fetal Doppler FDA verified
Flyte FDA verified
INVU by Nuvo FDA verified
Mcare FDA verified

All certified women's health and fertility apps and devices

Search the full directory