Papers, Ion
Which Manufacturers in China Make This?
6 manufacturers in China hold an FDA registration for this device type, concentrated in Fujian, Guangdong and Hong Kong, and 2 other provinces.
- Dongguan City Ruimi Gift Products Co Ltd Guangdong
- Honghu Danielle Sanitary Material Co., Ltd. Hubei, contract manufacturer
- Ningbo Tianbo First AID Product Co., Ltd. Zhejiang
- Objectt Optik Company Limited Hong Kong, contract manufacturer
- Quanzhou Apex Hygiene Products Co., Ltd. Fujian
- Quanzhou Goooing Corporation Fujian
How Is DMG Classified?
Papers, Ion is FDA product code DMG, Class 1, 21 CFR 862.2230.
How Does It Reach the US Market?
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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