Is One Drop I Mobile FDA approved or cleared?
Not as such. AgaMatrix (for One Drop) holds a 510(k) clearance for related hardware, latest decision in 2016, but One Drop I Mobile itself is not named in the FDA record.
In the EU: no CE listing found in EUDAMED. Not every CE-marked device is registered there yet.
This product appears to be discontinued or no longer supported by its maker.
At a glance
| Product | One Drop I Mobile |
|---|---|
| Maker | AgaMatrix (for One Drop) |
| Care area | Diabetes & metabolism |
| What it does | Bluetooth glucose meter with comprehensive diabetes management app |
| FDA | 510(k), latest decision 2016 (product family) |
| Verification level | Related hardware authorised; this app itself is not named (checked 18 October 2026) |
| EU (CE) | No CE listing found |
| Website | ambrosiasys.com |
| 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
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