Medical Device Manufacturer · CN , Baoshan District

Shanghai Handy Medical Equipment Co., Ltd. - FDA 510(k) Cleared Devic...

1 submissions · 1 cleared · Since 2022

1

Total

1

Cleared

0

Denied

FDA 510(k) Regulatory Record - Shanghai Handy Medical Equipment Co., Ltd. Radiology ✕

1 devices

1-1 of 1

Cleared Jun 22, 2022

HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)

Radiology · 78d

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 21, 2026