Purifier, Water, Ultraviolet, Medical
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are based in Jiangsu and Zhejiang: 2 hold an FDA registration.
- Aopu Lighting (Jinyun) Co., Ltd. Zhejiang, contract manufacturer
- Jiangyin Binjiang Medical Equipment Co., Ltd. Jiangsu
What Is FDA Product Code KMG?
Purifier, Water, Ultraviolet, Medical is FDA product code KMG, Class 2, 21 CFR 880.6710.
What Does It Take to Sell It in the United States?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.
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