Is FD200 Fetal Doppler FDA approved or cleared?
Not as such. Huntleigh Healthcare Ltd. holds a 510(k) clearance for related hardware, but FD200 Fetal Doppler 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.
At a glance
| Product | FD200 Fetal Doppler |
|---|---|
| Maker | Huntleigh Healthcare Ltd. |
| Care area | Women's health & fertility |
| What it does | Handheld fetal Doppler device for monitoring fetal heart rate during pregnancy |
| FDA | 510(k) (product family) |
| Verification level | Related hardware authorised; this app itself is not named (checked 18 October 2026) |
| EU (CE) | No CE listing found |
| Website | huntleigh-diagnostics.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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