Bath, Flotation, Tissue
Which Manufacturers in China Make This?
6 manufacturers in China hold an FDA registration for this device type, concentrated in Shanghai, Zhejiang and Fujian, and 1 other province.
- Guangzhou Four E's Scientific Co., Ltd. Guangdong, contract manufacturer
- Jinhua Craftek Instrument Co., Ltd. Zhejiang
- Leica Instruments (Shanghai) Co., Ltd. Shanghai, contract manufacturer
- Quanzhou V-Care Sanitary Products Co., Ltd. Fujian
- Shanghai Youding International Trade Co., Ltd. Shanghai
- Zhejiang Gene Science Co., Ltd. Zhejiang
How Is IDY Classified?
Bath, Flotation, Tissue is FDA product code IDY, Class 1, 21 CFR 864.3010.
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.
What Do the Recalls Say?
The FDA has recorded 1 recall under this product code since 2008. None was by a company in China. The root cause the FDA records most often is Device Design (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
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