Bottle, Blow
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are based in Zhejiang and Jiangsu: 3 hold an FDA registration. 2 are contract manufacturers.
- Danyang NEW Hope Medical Equipment Co., Ltd. Jiangsu
- Hangzhou Rollmed Co., Ltd. Zhejiang, contract manufacturer
- Zhejiang Fansl Clothing Co., Ltd. Zhejiang, contract manufacturer
How Is BYO Classified?
Bottle, Blow is FDA product code BYO, Class 1, 21 CFR 868.5220.
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. It is also exempt from most of the quality system regulation.
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