Light, Wood’S, Fluorescence
Which Manufacturers in China Make This?
3 manufacturers in China hold an FDA registration for this device type, concentrated in Guangdong, Hubei and Jiangsu.
- Wuhan Zjzk Technology Co., Ltd. (AKA Wuhan Zjkc Technology Co., Ltd.) Hubei
- Xuzhou Kernel Medical Equipment Co Ltd Jiangsu, contract manufacturer
- Ziree (Shenzhen) Medical Technology Co., Ltd. Guangdong
What Is FDA Product Code GMB?
Light, Wood’S, Fluorescence is FDA product code GMB, Class 1, 21 CFR 866.2600.
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. It is also exempt from most of the quality system regulation.
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