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US
Last updated May 23, 2026
What Ningbo Huakun Medical Equipment Co., Ltd. makes
Ningbo Huakun Medical Equipment Co., Ltd. manufactures heat and moisture exchangers (HMEs) and associated filter devices, which are used in respiratory therapy to humidify and filter inhaled air for patients.
These products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. 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 Ningbo Huakun Medical Equipment Co., Ltd. manufacture?
Ningbo Huakun Medical Equipment Co., Ltd. specializes in heat and moisture exchangers (HMEs) and filter devices. These products are designed for respiratory therapy to humidify and filter the air patients inhale, ensuring cleaner and more comfortable breathing during medical procedures.
Where is Ningbo Huakun Medical Equipment Co., Ltd. based?
The company is based in the United States. While the name suggests a Chinese origin, its operational headquarters and manufacturing presence are located within the US.
How are the devices manufactured by Ningbo Huakun Medical Equipment Co., Ltd. classified under FDA regulations?
The devices produced by Ningbo Huakun Medical Equipment Co., Ltd., such as HMEs and filters, are classified as Class II medical devices under FDA regulations. This classification typically applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness.
Which regulatory registries or pathways list the devices made by Ningbo Huakun Medical Equipment Co., Ltd.?
The devices manufactured by Ningbo Huakun Medical Equipment Co., Ltd. are listed through the FDA’s 510(k) pathway. This pathway is used to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, ensuring compliance with regulatory requirements before market introduction.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (1)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Filter and HME/Filter | K221472 | 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.
- Ningbo Huakun Medical Equipment Co., Ltd Cixi Zhejiang · CN FEI 3009747810