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Is PherDal At-Home Insemination FDA approved or cleared?

Yes. PherDal At-Home Insemination by PherDal Fertility Science, Inc. is named in the FDA register with a 510(k) clearance, latest decision in 2023.

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

At a glance

Product	PherDal At-Home Insemination
Maker	PherDal Fertility Science, Inc.
Care area	Women's health & fertility
What it does	At-home artificial insemination kit and fertility support system
FDA	510(k), latest decision 2023
Verification level	Exact product named in the FDA record (checked 18 October 2026)
EU (CE)	No CE listing found
Website	pherdal.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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