Guangdong Horigen Mother & Baby Products Co., Ltd.
Manufacturer and brand owner in Shantou, Guangdong, China. 3 device types, 4 products catalogued, 7 clearances.
Guangdong Horigen Mother & Baby Products Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Pump, Breast, Powered, Irrigator, Powered Nasal and 1 other device type. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2014.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3009700166 |
| FEI number | 3009700166 |
| DUNS | 529354502 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 广东好女人母婴用品股份有限公司 |
|---|---|
| Unified social credit code | 9144051372706956XE |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shantou |
|---|---|
| Province | Guangdong |
| Address | No. 18, Pingnan Industrial Zone, Mianbei Street |
| Postal code | 515100 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Irrigator, Powered Nasal | Class 1 | Electric nasal irrigator(XB-F001) | 2024 | 63 |
| Pump, Breast, Non-Powered | Class 1 | Manual Breast Pump | 2016 | 33 |
| Pump, Breast, Powered | Class 2 | Portable Double electric breast pump(Model:XN-2223M2), Electric Breast Pump, Electric Breast Pump (Model: SMG, GEA, SMG2, GEA2, GW), Electric breast pump (Model: MF1, F6, K3), Electric breast pump(XN/MD-6602A), Electric breast pump (Model:XN/MD-2267R) and 22 more | 2014 | 40 |
Own-Brand Listings
Clearances
7 clearances name Guangdong Horigen Mother & Baby Products Co., Ltd. as applicant. 2 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K262774 | 2026-09-01 | HGX | Traditional | This company |
| K212564 | 2022-05-06 | HGX | Traditional | This company |
| K201152 | 2021-05-04 | HGX | Traditional | This company |
| K201974 | 2021-03-07 | FXX | Traditional | This company |
| K193449 | 2020-09-11 | HGX | Traditional | This company |
| K182413 | 2019-03-07 | HGX | Traditional | This company |
| K162747 | 2016-12-08 | HGX | Traditional | This company |
| K143585 | 2015-05-06 | HGX | Traditional | Shantou Xinghe Electrical Apparatuses Co., Ltd. |
| K132882 | 2014-04-24 | HGX | Traditional | Shantou Xinghe Electrical Apparatuses Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2003 |
|---|---|
| Factory area | 12000 square meters |
| Main products | electric breast pumps, breast milk storage products, baby heating appliances, baby feeding products |
| Certifications | ISO9001, ISO14001, ISO13485 |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.