Medical Device Manufacturer · CN , Ningbo

Ningbo Baichen Medical Devices Co., Ltd. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2023

Total

Cleared

Denied

FDA 510(k) Regulatory Record - Ningbo Baichen Medical Devices Co., Ltd. Physical Medicine ✕

3 devices

1-3 of 3

Regulatory consultants 510(k) submission support ecosystem

Shanghai SUNGO Management Consulting Co., Ltd.

Shanghai Sungo Management Consulting Company Limited.

Regulatory activity signals

510(k) clearance pathway relevance detected

Medical device regulatory intelligence node

Consulting ecosystem involvement present

Data Source

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

Last updated: Apr 27, 2026