Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009700166

FEI Number

3009700166

Entity Name

Guangdong Horigen Mother & Baby Products Co., Ltd.

City/State/Country

Shantou Guangdong, CN

Establishment Address

No. 18, Pingnan Industrial Zone, Mianbei Street, Chaoyang District, Shantou Guangdong 515100, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Guangdong Horigen Mother & Baby Products Co., Ltd. (Owner Number: 10046724)

Owner / Operator Contact Address

No. 18, Pingnan Industrial Zone, Mianbei Street, Chaoyang District, Shantou, CN-GD 515100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K201974

PMA Number

N/A

All Registered Proprietary Names

Electric Breast Pump Portable Double electric breast pump(Model:XN-2223M2) Electric Breast Pump (Model: SMG, GEA, SMG2, GEA2, GW) Nanobebe Wearable Breast Pump (Model: FUS8510110);Nanobebe Wearable Breast Pump (Model: FUS8510210) Electric breast pump (Model: XN/MD-2267A,XN/MD-2267B,XN/MS-2238A,XN/MS-2246A) V6CO Pump-Y Electronic Double Breast Pump (Model: PY-1016A) Electric breast pump(model:2259C) Electric breast pump (Model: XN/MD-2249BS) Biamba Pump Pro (Model:Bvk 20) Double electric breast pump (Model: HD2721, XN/MS-2242A) Electric breast pump(Model:D6) Proture Double Electric Breast Pump(Model:XN-2208H2) Biamba Pump Pro New (Model: Bvk 20up) Electric breast pump(Model:Nurseva Pro-90A) Electric breast pump(XN/MD-6602A) Miture/ Niture Electric Breast Pump Electric breast pump(XN/MS-6603A) Single Electric Breast Pump(Item NO.:RTLBP1000);Double Electric Plus Breast Pump(Item NO.:RTLBP2000) Electric Breast Pump Electric breast pump (Model:XN/MD-2267R) Hands-Free Double Electric Breast Pump(model:R1;R3;R5 Pro) Electric breast pump (Model: ID2, HD2715, XN/MD-2267K) Electric breast pump(XN/MD-6601A) Electric breast pump (Model: MF1, F6, K3) Single-use Medical Face Mask Electric nasal irrigator(model:XB-F001) Double Electric Plus Breast Pump(Item NO.:RTLBP0200) Electric Breast Pump (Model No.: ZFHF) 2 in 1 lactation massager (model: B25650CQ),2 in 1 lactation massager (model: F8) Biamba Massage-Cool (Model: Bv20) Biamba Massage-Heat(Model: Bv19) Single-use medical face mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2019-03-11
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2022-05-25
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2016-12-12
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2015-05-07
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-06-01
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	Class 1	874.5550	2024-01-15
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2014-05-04
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2024-07-23
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-03-08

Official Correspondent

Changxin Chen

US Agent Details

Cancan Huang Business: Osmunda Technology Co., Ltd. Email: sunny.huang@osmundacn.com Phone: (858) 3571157

Related Public Records

Same Entity

Guangdong Horigen Mother & Baby Products Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K190465	Hygeia II Medical Group, Inc.	Evolve Breast Pump	2019-10-18
K021739	Limerick, Inc.	LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002	2003-01-10
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009700166. Last updated year: 2026. Please use registration number 3009700166 when referencing this establishment in official correspondence.