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.

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 . 174,883 total devices indexed.

Last updated: Apr 27, 2026