Shenzhen Changkun Technology Co., Ltd. is one of 2114 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.
Shenzhen Changkun Technology Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3), Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303), Electric Breast Pump
7
Total
7
Cleared
0
Denied
Shenzhen Changkun Technology Co., Ltd. has 7 FDA 510(k) cleared medical devices. Based in Shenzhen, CN.
Latest FDA clearance: Jun 2026. Active since 2020.
Browse the FDA 510(k) cleared devices submitted by Shenzhen Changkun Technology Co., Ltd. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Guangzhou GLOMED Biological Technology Co., Ltd., Shenzhen Reanny Medical Devices Mgmt Consulting Co., Ltd. and Shenzhen Reanny Medical Devices Management Consulting Co., Ltd..
FDA 510(k) Regulatory Record - Shenzhen Changkun Technology Co., Ltd.
7 devices
Cleared
Jun 26, 2026
Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)
Obstetrics & Gynecology
532d
Cleared
May 06, 2026
Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)
Gastroenterology & Urology
266d
Cleared
Oct 26, 2023
Electric Breast Pump
Obstetrics & Gynecology
147d
Cleared
May 04, 2023
Finger Pulse Oximeter, Model: X1906P
Anesthesiology
317d
Cleared
Jan 27, 2021
Wrist Electronic Sphygmomanometer
Cardiovascular
418d
Cleared
Jan 27, 2021
Arm Electronic Sphygmomanometer
Cardiovascular
418d
Cleared
Jun 17, 2020
Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503
General Hospital
212d