Medical Device Manufacturer · CN , Shantou

Guangdong Horigen Mother & Baby Products Co., Ltd. - FDA 510(k) Clear...

7 submissions · 7 cleared · Since 2016

Recent clearances: Wearable breast pump (Model: XN/MD-2249BS, ZFHF), Electric Breast Pump, Electric Breast Pump

Total

Cleared

Denied

Guangdong Horigen Mother & Baby Products Co., Ltd. has 7 FDA 510(k) cleared medical devices. Based in Shantou, CN.

Latest FDA clearance: Sep 2026. Active since 2016. Primary specialty: Obstetrics & Gynecology.

Browse the FDA 510(k) cleared devices submitted by Guangdong Horigen Mother & Baby Products Co., Ltd. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Guangzhou Osmunda Medical Device Technical Service Co., Ltd., Guangzhou Osmunda Medical Device Technical Services Co., Ltd. and Regulatory Technology Services, LLC.

Guangdong Horigen Mother & Baby Products Co., Ltd. is one of 2116 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.