Shenzhen HugeMed Medical Technical Development Co., Ltd. is one of 1554 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.
Shenzhen HugeMed Medical Technical Development Co., Ltd. - FDA 510(k)...
Recent clearances: Suction Pump (SU-90), Single-use Ureteral Access Sheath, Biliary Pancreaticobiliary Scope System
8
Total
8
Cleared
0
Denied
Shenzhen HugeMed Medical Technical Development Co., Ltd. has 8 FDA 510(k) cleared medical devices. Based in Shenzhen, CN.
Latest FDA clearance: May 2026. Active since 2023. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by Shenzhen HugeMed Medical Technical Development Co., Ltd. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Shenzhen Chonconn Medical Device Consulting Co., Ltd. and Shenzhen Chonconn Medical Consulting Co., Ltd..
FDA 510(k) Regulatory Record - Shenzhen HugeMed Medical Technical Development Co., Ltd.
8 devices
Cleared
May 14, 2026
Suction Pump (SU-90)
General & Plastic Surgery
57d
Cleared
Jul 08, 2025
Single-use Ureteral Access Sheath
Gastroenterology & Urology
123d
Cleared
Jan 21, 2025
Biliary Pancreaticobiliary Scope System
Gastroenterology & Urology
244d
Cleared
May 10, 2024
Ureterorenoscope System
Gastroenterology & Urology
93d
Cleared
Apr 26, 2024
Rhinolaryngoscope system
Ear, Nose, Throat
256d
Cleared
Mar 06, 2024
Choledochoscope System
Gastroenterology & Urology
287d
Cleared
Nov 13, 2023
Cystoscope System
Gastroenterology & Urology
207d
Cleared
Apr 11, 2023
Bronchoscope System
Ear, Nose, Throat
197d