Solution, Isotonic
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are concentrated in Zhejiang, Guangdong and Jiangsu, and 3 other provinces: 16 hold an FDA registration. 3 are contract manufacturers.
- Bestreat Safety & First AID Solution Co., Ltd. Hubei
- Dongguan City Ruimi Gift Products Co Ltd Guangdong
- Guangdong Comfort Medical Products Co., Ltd. Guangdong
- Guangzhou Nuoning Medical Supplies Co., Ltd. Guangdong, contract manufacturer
- Hangzhou Aosi Healthcare Co., Ltd. Zhejiang, contract manufacturer
- Hefei Haixi Trading Co., Ltd. Anhui
- Hunan Pinliu Biological Technology Co., Ltd. Hunan
- Hubei Lanbin Medical Group Co., Ltd. Hubei, contract manufacturer
- Nantong Kangjinchen Medical Equipment Co., Ltd. Jiangsu
- Ningbo Jenius Polymer SCI-Tech Co., Ltd. Zhejiang
- Ningbo Tianbo First AID Product Co., Ltd. Zhejiang
- Saferlife Products Co., Ltd. Guangdong, contract manufacturer
- Suzhou Pulikang Medical Device Co Ltd Jiangsu
- Taizhou Xinkang Medical Materials Co., Ltd. Jiangsu, contract manufacturer
- Yiwu Ori-Power Medtech Co., Ltd. Zhejiang, contract manufacturer
- Zhejiang Changdi Medical Co., Ltd. Zhejiang, contract manufacturer
What Is FDA Product Code JCE?
Solution, Isotonic is FDA product code JCE, Class 1, 21 CFR 864.4010.
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.
Name
Record
Thermo Scientific Nerl®
4 catalogue numbers from 9805, listed by Fisher Diagnostics, United States, under Solution, Isotonic. 16 manufacturers in China are registered for this product code.