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Is Trak: Sperm Health & Fertility FDA approved or cleared?

Yes. Trak: Sperm Health & Fertility by Sandstone Diagnostics, Inc. is named in the FDA register with a 510(k) clearance, first authorised in 2016, latest decision in 2017.

In the EU: no CE listing found in EUDAMED. Not every CE-marked device is registered there yet.

At a glance

Product	Trak: Sperm Health & Fertility
Maker	Sandstone Diagnostics, Inc.
Care area	Women's health & fertility
What it does	At-home male fertility testing system with sperm count and quality analysis
FDA	510(k), latest decision 2017
Verification level	Exact product named in the FDA record (checked 18 October 2026)
EU (CE)	No CE listing found
Website	trakfertility.com
Status	FDA verified
Last checked	6 October 2026

Certification status can change. Always confirm in the official register before relying on it: the FDA databases, EUDAMED or the BfArM DiGA directory.

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