Medical Device Manufacturer · CN , Zibo

Shinva Ande Healthcare Apparatus Co., Ltd. - FDA 510(k) Cleared Devic...

6 submissions · 6 cleared · Since 2017

Total

Cleared

Denied

FDA 510(k) Regulatory Record - Shinva Ande Healthcare Apparatus Co., Ltd. Gastroenterology & Urology ✕

1 devices

1-1 of 1

Regulatory consultants 510(k) submission support ecosystem

Beijing Believe-Med Technology Service Co., Ltd.

Guangzhou Osmunda Medical Device Technical Service 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 18, 2026