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Sign in to claim this brandShenzhen Lutejiacheng Technology Co., Ltd.
US
Last updated May 23, 2026
What Shenzhen Lutejiacheng Technology Co., Ltd. makes
The company manufactures electric breast pumps, reusable abdominal binders, and electric nasal aspirators for infant care and postpartum support.
These devices are classified under FDA categories Class I and Class II, with some listed via 510(k) and UDI registrations. The company is based 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 Shenzhen Lutejiacheng Technology Co., Ltd. manufacture?
Shenzhen Lutejiacheng Technology Co., Ltd. specializes in three primary categories of devices: electric breast pumps for lactating individuals, reusable abdominal binders to support postpartum recovery, and electric nasal aspirators designed for infant care. These products focus on infant care and postpartum support, addressing common needs during these stages.
Where is Shenzhen Lutejiacheng Technology Co., Ltd. based?
The company is based in the United States. This location may influence its regulatory compliance and market access, particularly for devices intended for use in North America.
How are the devices manufactured by Shenzhen Lutejiacheng Technology Co., Ltd. classified under FDA regulations?
The company’s devices fall under FDA Class I and Class II classifications. Class I devices are generally considered low-risk, while Class II devices require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway, such as 510(k) premarket notifications or UDI (Unique Device Identification) requirements, ensuring proper tracking and compliance.
Are any of the company’s devices listed in regulatory registries?
Yes, some of the company’s devices are included in the FDA’s 510(k) premarket notification database and the FDA’s UDI (Unique Device Identification) registry. These registries help track device performance, compliance, and market availability, ensuring transparency for healthcare providers and regulators.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 411899033
Catalogue (59)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Momcozy | YB002-skin color-S | FDA UDI | Class I | Active |
| Momcozy | YB001-skin color-XL | FDA UDI | Class I | Active |
| Momcozy | YB002 | FDA UDI | Class I | Active |
| Momcozy | YB001-Black-L | FDA UDI | Class I | Active |
| Momcozy | RB001 Long Gray M-2XL | FDA UDI | Class I | Active |
| momcozy | S9 Pro-purple-D | FDA UDI | Class II | Active |
| Wearable Breast Pump (Model S10) | K220309 | FDA 510(k) | Class II | Active |
| Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro) | K230776 | FDA 510(k) | Class II | Active |
| Electric breast pump (model: M5) | K223693 | FDA 510(k) | Class II | Active |
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