Certified Health Apps

All apps · Women's health & fertility

Certified women's health and fertility apps and devices

41 women's health apps and devices, each checked against the FDA register, EUDAMED and the German DiGA directory. Last checked 18 October 2026.

22FDA verified
4CE class IIa or higher
7German DiGA
5no matching FDA record

Women's health is growing fast: a cleared contraception app, home cervical screening, home ultrasound in pregnancy, pelvic floor trainers and fertility devices. Germany reimburses apps for endometriosis, period pain, menopause and pelvic floor training.

Below you find every women's health and fertility tool we track, grouped by what we could verify in the official registers.

Digital women's health: the certified landscape 2026
Our women's health landscape for pharma, payers and hospitals: 4 segments, 41 tools, with an auditable verification level for every FDA entry. See the report · Free sample
eBook: What the Label Doesn't Say, with the Perifit example See guides and reports

In the US: FDA verified (22)

Authorised by the FDA (510(k), De Novo or PMA), newest decisions first.

In the EU: CE class IIa or higher (4)

Found in EUDAMED as class IIa or higher. We show whether a notified body certificate is visible there.

In Germany: DiGA (7)

Listed in the German directory of reimbursed digital health applications.

CE class I (self-declared) (3)

Self-declared by the maker, without review by a notified body. We list these apart.

Watchlist (5)

These products are presented as certified, by their maker or in earlier directories, but we found no matching record in the official register, or they are no longer supported by their maker. Some are registered and listed with the FDA as exempt devices, which is legal but is not a clearance.

The trap to avoid

Fertility and hormone trackers are the most mislabelled group in this area. Five products are on our watchlist because their claimed FDA status could not be confirmed under their name. Brand and maker names also differ often: Perifit is registered by X6 Innovations.

Questions

Is there an FDA-cleared contraception app?

Yes. Natural Cycles holds a 510(k), with the most recent decision in our directory from 2026.

Can cervical cancer screening be done at home?

The Teal Wand, a self-collection device, was authorised by the FDA through the De Novo route in 2025.

Are hormone trackers like Mira or Oova FDA cleared?

We could not confirm an FDA authorisation under their names, so both are on our watchlist. That does not mean the products do not work; it means the claim could not be verified in the register.

Which women's health apps are reimbursed in Germany?

The DiGA directory lists, among others, Endo-App for endometriosis, Pia-App for period pain, isi PMS App, Vera-App and Frieda Menova.

Certification status changes. Always confirm in the official register before relying on it. Not medical advice.

Search the full directory · Free guide: how to check a health app in two minutes