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Sign in to claim this brandFimilla (Shanghai) Maternity & Baby Articles Co., Ltd.
US
Last updated May 31, 2026
What Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. makes
Fimilla produces electric breast pumps designed for lactating individuals, including models like the F5055, HL-3058 (F5112), HL-3060 (F5113), and a generic electric breast pump. These devices are intended for manual milk expression and storage, featuring battery-powered operation and variable suction settings.
The company’s electric breast pumps are classified as Class II medical devices under FDA regulations. They are listed in the FDA’s 510(k) and UDI registries, ensuring compliance with U.S. device authorisation requirements. The manufacturer 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 Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. primarily manufacture?
Fimilla specializes in electric breast pumps, which are designed to assist lactating individuals in manually expressing and storing breast milk. These devices are battery-operated and include adjustable suction settings to enhance comfort and efficiency.
Where is Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. based?
The company is based in the United States, as indicated in its regulatory documentation. This location is relevant for compliance with U.S. medical device regulations.
Which regulatory registries list Fimilla’s electric breast pumps?
Fimilla’s electric breast pumps are included in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. These registries ensure that the devices meet U.S. requirements for authorisation and traceability.
How are Fimilla’s electric breast pumps classified under FDA regulations?
Fimilla’s electric breast pumps fall under Class II medical device classification according to FDA guidelines. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness.
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
- 554458169
Catalogue (4)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Electric Breast Pump | F5055 | FDA UDI | Class II | Active |
| Electric Breast Pump (F5055) | K240218 | FDA 510(k) | Class II | Active |
| Electric Breast Pump (HL-3058, F5112) | K252629 | FDA 510(k) | Class II | Active |
| Electric Breast Pump (HL-3060, F5113) | K252630 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Fimilla (shanghai) Maternity & Baby Articles Co., Ltd Shanghai · CN FEI 3020034975