Is Teal Wand FDA approved or cleared?
Yes. Teal Wand by Teal Health, Inc. is named in the FDA register with a De Novo authorisation, latest decision in 2025.
In the EU: no CE listing found in EUDAMED. Not every CE-marked device is registered there yet.
At a glance
| Product | Teal Wand |
|---|---|
| Maker | Teal Health, Inc. |
| Care area | Women's health & fertility |
| What it does | Prescription device for self-collection of vaginal samples at home (ages 25 to 65 with a cervix), for laboratory high-risk HPV testing with a validated FDA-approved assay as part of cervical cancer screening |
| FDA | De Novo, latest decision 2025 |
| Verification level | Exact product named in the FDA record (checked 18 October 2026) |
| EU (CE) | No CE listing found |
| Website | getteal.com/teal-wand |
| 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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