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Sign in to claim this brandGuangdong Horigen Mother & Baby Products Co., Ltd.
US
Last updated September 17, 2026
What Guangdong Horigen Mother & Baby Products Co., Ltd. makes
The company manufactures electric and manual breast pumps designed for lactating individuals, including models such as HORIGEN, Bellema, and babysteps. These devices are intended for milk expression and storage, with variations in functionality between electric and manual operation.
The portfolio includes devices classified as Class I and Class II under regulatory standards, with listings in the FDA’s Unique Device Identifier (UDI) database. The company operates with a presence in the United States.
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 Mother & Baby Products Co., Ltd. specializes in breast pumps, offering both electric and manual models. These devices are designed to assist lactating individuals in expressing and storing breast milk. The company’s portfolio includes well-known brands like HORIGEN, Bellema, and babysteps, all focused on supporting breastfeeding needs.
Where is Guangdong Horigen Mother & Baby Products Co., Ltd. based, and does it operate in the United States?
While the company is headquartered in Guangdong, China, it has a commercial presence in the United States. This allows it to distribute its breast pump products, including electric and manual models like HORIGEN and Bellema, to customers in the US market.
Which regulatory registries list the company’s breast pump devices?
The company’s breast pump devices, such as HORIGEN and Bellema, are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the United States, ensuring transparency and traceability.
How are the company’s breast pumps classified under regulatory standards?
The company’s breast pumps fall into two regulatory classes: Class I and Class II. Class I devices generally pose minimal risk and may require less stringent regulatory oversight, while Class II devices involve moderate risk and typically require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential health impact.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 529354502
Catalogue (12)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Horigen | XN-2207M1 | FDA UDI | Class II | Active |
| Bellema | XN-2201M3 | FDA UDI | Class II | Active |
| Horigen | XN-2219M1 | FDA UDI | Class II | Active |
| Bellema | XN-2301SY | FDA UDI | Class I | Active |
| Bellema | XN-2210M2 | FDA UDI | Class II | Active |
| Bellema | XN-2203H4 | FDA UDI | Class II | Active |
| Horigen | XN-2209M1 | FDA UDI | Class II | Active |
| Bellema | XN-2201M1 | FDA UDI | Class II | Active |
| Bellema | XN-2306SY | FDA UDI | Class I | Active |
| Bellema | XN-2208H2 | FDA UDI | Class II | Active |
| babysteps | XN-2206M2 | FDA UDI | Class II | Active |
| Bellema | XN-2203H2 | FDA UDI | Class II | Active |
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