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Guangdong Horigen Mother & Baby Products Co., Ltd.: FDA-registered device maker in Shantou Guangdong, China, 7 510(k) clearances

Name: Guangdong Horigen Mother & Baby Products Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Guangdong Horigen Mother & Baby Products Co., Ltd. is registered with the FDA (registration 3009700166) in Shantou Guangdong, China. It lists 3 device types. The FDA files 7 510(k) clearances under its listings, the newest dated September 1, 2026. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3009700166
Address: No. 18, Pingnan Industrial Zone, Mianbei Street Chaoyang District, Shantou Guangdong, China, 515100
Owner or operator: Guangdong Horigen Mother & Baby Products Co., Ltd. (10046724)
Roles: Manufacturer
First device listed: May 4, 2014
Registered through: 2026
Brand names listed: Biamba Pump Pro New(Model: Bvk 20up); Biamba Ultra One(Model:XN/MD-6611R), Electric Breast Pump, Electric Breast Pump (Model: SMG, GEA, SMG2, GEA2, GW), Electric Breast Pump; Portable Double electric breast pump(Model: XN/MS-2246A), Electric breast pump(Model:D6); Electric breast pump(Model:D7), Electric breast pump(Model:K3); Electric breast pump(Model:F6); Electric breast pump(Model:M7), Electric breast pump(Model:MN-H1), Electric breast pump(Model:Nurseva Pro-90A) and more

Devices it lists

Device	Product code	Class	Role	Source
Irrigator, Powered Nasal	KMA	1	Manufacturer	accessdata.fda.gov
Pump, Breast, Non-Powered	HGY	1	Manufacturer	accessdata.fda.gov
Pump, Breast, Powered	HGX	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 1, 2026	K262774	Wearable breast pump (Model: XN/MD-2249BS, ZFHF)	HGX	Substantially Equivalent	Guangdong Horigen Mother & Baby Products Co., Ltd.	accessdata.fda.gov
May 6, 2022	K212564	Electric Breast Pump	HGX	Substantially Equivalent	Guangdong Horigen Mother & Baby Products Co., Ltd.	accessdata.fda.gov
May 4, 2021	K201152	Electric Breast Pump	HGX	Substantially Equivalent	Guangdong Horigen Mother & Baby Products Co., Ltd.	accessdata.fda.gov
March 7, 2019	K182413	Electric Breast Pump	HGX	Substantially Equivalent	Guangdong Horigen Mother & Baby Products Co., Ltd.	accessdata.fda.gov
December 8, 2016	K162747	Proture Double Electric Breast Pump	HGX	Substantially Equivalent	Guangdong Horigen Mother & Baby Products Co., Ltd.	accessdata.fda.gov
May 6, 2015	K143585	Electric Breast Pump	HGX	Substantially Equivalent	Shantou Xinghe Electrical Apparatuses Co., Ltd.	accessdata.fda.gov
April 24, 2014	K132882	ELECTRIC BREAST PUMP	HGX	Substantially Equivalent	Shantou Xinghe Electrical Apparatuses Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated September 1, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.