All apps · Diabetes & metabolism

Is CeQur Simplicity FDA approved or cleared?

Yes. CeQur Simplicity by CeQur SA is named in the FDA register with a 510(k) clearance, first authorised in 2024, latest decision in 2026.

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

At a glance

Product	CeQur Simplicity
Maker	CeQur SA
Care area	Diabetes & metabolism
What it does	Wearable 3-day insulin patch for mealtime doses at the press of a button
FDA	510(k), latest decision 2026
Verification level	Exact product named in the FDA record (checked 18 October 2026)
EU (CE)	No CE listing found
Website	myceqursimplicity.com
Status	FDA verified
Last checked	7 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 Diabetes & metabolism

Accu-Chek Connect app FDA verified
AgaMatrix Diabetes Manager FDA verified
Bigfoot Unity™ FDA verified
Biolinq Shine FDA verified
BlueStar® FDA verified
Contour Diabetes App FDA verified
Dario Blood Glucose Monitor FDA verified
DBLG2 System FDA verified

All certified diabetes apps and devices

Search the full directory