Is Freestyle Libre 2 Plus FDA approved or cleared?
Partly. Freestyle Libre 2 Plus belongs to a product family by Abbott Diabetes Care that holds a 510(k) clearance, latest decision in 2024, but this exact variant or app is not named in the FDA record.
In the EU: CE class IIb, found in EUDAMED. No notified body certificate is visible in EUDAMED yet; ask the maker for it (devices still under the older MDD rules often have none listed).
At a glance
| Product | Freestyle Libre 2 Plus |
|---|---|
| Maker | Abbott Diabetes Care |
| Care area | Diabetes & metabolism |
| What it does | Enhanced version of Libre 2 with additional features and connectivity options |
| FDA | 510(k), latest decision 2024 (product family) |
| Verification level | Product family authorised; this exact variant or app is not named (checked 18 October 2026) |
| EU (CE) | Class IIb |
| EU certificate | Not visible in EUDAMED yet (checked 18 October 2026) |
| Website | freestyle.abbott |
| Status | FDA verified |
| Last checked | 6 October 2026 |
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
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
- AgaMatrix Diabetes Manager
- Bigfoot Unity™
- Biolinq Shine
- BlueStar®
- CeQur Simplicity
- Contour Diabetes App
- Dario Blood Glucose Monitor