Medical Device Manufacturer · CN , Suzhou

Suzhou Colour-Way New Material Co., Ltd. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2022

Total

Cleared

Denied

FDA 510(k) Regulatory Record - Suzhou Colour-Way New Material Co., Ltd. General Hospital ✕

2 devices

1-2 of 2

Regulatory consultants 510(k) submission support ecosystem

Shanghai Sungo Management Consulting Company Limited.

Shanghai SUNGO Management Consulting Co., Ltd.

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: May 11, 2026