Medical Device Manufacturer · AU , Sydney

Genea Biomedx Pty, Ltd. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2017

Total

Cleared

Denied

Genea Biomedx Pty, Ltd. has 6 FDA 510(k) cleared medical devices. Based in Sydney, AU.

Historical record: 6 cleared submissions from 2017 to 2018. Primary specialty: Obstetrics & Gynecology.

Browse the FDA 510(k) cleared devices submitted by Genea Biomedx Pty, Ltd. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Donawa Lifescience Consulting Srl as regulatory consultant.

Genea Biomedx Pty, Ltd. is one of 80 FDA 510(k) medical device manufacturers from Australia in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Genea Biomedx Pty, Ltd.

6 devices

1-6 of 6

Data Source

Sourced from the FDA 510(k) public files . 175,450 total devices indexed.

Last updated: Jun 08, 2026