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Sign in to claim this brandGuangdong Horigen Mother & Baby Products Co., Ltd.
China·CN-MF-000021982
Last updated September 17, 2026
What Guangdong Horigen Mother & Baby Products Co., Ltd. makes
Guangdong Horigen produces manual and electric breast pumps, including single and double models such as the Proture Double Electric Breast Pump and the KP033_01/KP053_01 series. Their portfolio also includes single-use medical face masks branded under HORIGEN.
The company’s products are classified as Class I, Class II, and Class IIa devices. Their breast pumps and face masks are listed in the EU’s eudamed registry and have undergone FDA 510(k) clearance. The manufacturer is based in China.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Guangdong Horigen Mother & Baby Products Co., Ltd. manufacture?
Guangdong Horigen specializes in breast pumps and single-use medical face masks. Their product line includes both manual and electric breast pumps, such as the Proture Double Electric Breast Pump and the KP033_01/KP053_01 series, which cover single and double models. Additionally, they produce single-use medical face masks under the HORIGEN brand.
Where is Guangdong Horigen Mother & Baby Products Co., Ltd. based?
The company is headquartered in Guangdong, China. This location serves as the primary base for their operations and manufacturing.
Which regulatory registries list devices manufactured by Guangdong Horigen?
Devices produced by Guangdong Horigen are listed in the EU’s eudamed registry, which tracks medical devices authorized within the European Economic Area. Additionally, some of their products, such as breast pumps, have undergone FDA 510(k) clearance, meaning they are included in the FDA’s 510(k) database in the United States.
How are the medical devices from Guangdong Horigen classified under regulatory standards?
The devices manufactured by Guangdong Horigen fall into different regulatory classes depending on their risk level and intended use. Their breast pumps and face masks are classified as Class I, Class II, or Class IIa devices. Class I devices are generally low-risk, while Class II and Class IIa devices involve moderate risks and require additional regulatory oversight to ensure safety and performance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- China
- Address
- No. 18, Pingnan Industrial Zone, Mianbei Street, Chaoyang District,Shantou, Guangdong, China
- Website
- horigen.cn
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- changxin chen
- EUDAMED SRN
- CN-MF-000021982
- FDA FEI Number
- 3009700166
- DUNS Number
- —
Catalogue (22)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Nimo | XN/MD-2267T | EUDAMED | Class IIa | Active |
| Horigen | XN-2223M1 | EUDAMED | Class IIa | Active |
| Proture Double Electric Breast Pump | K162747 | FDA 510(k) | Class II | Active |
| Electric Breast Pump | K212564 | FDA 510(k) | Class II | Active |
| Electric Breast Pump | K182413 | FDA 510(k) | Class II | Active |
| Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) | K193449 | FDA 510(k) | Class II | Active |
| Electric Breast Pump | K201152 | FDA 510(k) | Class II | Active |
| Single-use medical face mask | K201974 | FDA 510(k) | Class II | Active |
| Horigen | KP053_01 | EUDAMED | Class IIa | Active |
| Horigen | 204524 | EUDAMED | Class I | Active |
| Horigen | GEA | EUDAMED | Class IIa | Active |
| Horigen | SMG | EUDAMED | Class IIa | Active |
| Horigen | XN-2223M2 | EUDAMED | Class IIa | Active |
| Horigen | XN-2233M2 | EUDAMED | Class IIa | Active |
| Horigen | XN-2208HA | EUDAMED | Class IIa | Active |
| Horigen | XN/MS-2224A | EUDAMED | Class IIa | Active |
| Horigen | XN-2219M1 | EUDAMED | Class IIa | Active |
| Horigen | XN-2233M1 | EUDAMED | Class IIa | Active |
| Horigen | XN-2219M2 | EUDAMEDFDA UDI | Class IIa | Active |
| Horigen | KP033_01 | EUDAMED | Class IIa | Active |
| Horigen | XN-2212M2 | EUDAMEDFDA UDI | Class IIa | Active |
| Horigen | XN-2208HB | EUDAMED | Class IIa | Active |
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Authorities
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Guangdong Horigen Mother & Baby Products Co., Ltd. US