Certified Health Apps

All apps · Diabetes & metabolism

Is Omnipod DISPLAY & Omnipod VIEW FDA approved or cleared?

Not as such. Insulet Corporation holds a 510(k) clearance for related hardware, latest decision in 2019, but Omnipod DISPLAY & Omnipod VIEW itself is not named in the FDA record.

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

This product appears to be discontinued or no longer supported by its maker.

At a glance

ProductOmnipod DISPLAY & Omnipod VIEW
MakerInsulet Corporation
Care areaDiabetes & metabolism
What it doesDisplay and monitoring systems for Omnipod insulin management system
FDA510(k), latest decision 2019 (product family)
Verification levelRelated hardware authorised; this app itself is not named (checked 18 October 2026)
EU (CE)Class IIb
EU certificateLinked to the device record in EUDAMED (checked 18 October 2026)
Websiteinsulet.com
StatusFDA verified
Last checked6 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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