Iodine (Tincture)
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are concentrated in Zhejiang, Guangdong and Shandong: 5 hold an FDA registration.
- Dongyang City Yonoel Outdoor Products Co., Ltd. Zhejiang, contract manufacturer
- Firstar Healthcare Company Limited (Guangzhou) Guangdong, contract manufacturer
- Wenzhou Zhusi Medical Supplies Co., Ltd. Zhejiang, contract manufacturer
- Weihai Hongyu Nonwoven Fabric Products Co., Ltd. Shandong, contract manufacturer
- Yiwu Ori-Power Medtech Co., Ltd. Zhejiang, contract manufacturer
What Is FDA Product Code IAL?
Iodine (Tincture) is FDA product code IAL, Class 1, 21 CFR 864.4010.
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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