Clip, Removable (Skin)

Who Makes This Device Type in China?

15 manufacturers in China hold an FDA registration for this device type, concentrated in Jiangsu, Zhejiang and Shanghai, and 4 other provinces. 2 of them are contract manufacturers, able to build to a buyer’s own specification.

Beijing Tian Teng Cang YUE Trading Co., Ltd. Beijing, contract manufacturer
Bluemed Healthcare Co., Ltd. Shanghai
Boen Healthcare Co., Ltd. Jiangsu
Hangzhou Haizhu MIM Products Co., Ltd. Zhejiang
Jcmed Tianjin Import AND Export Co., Ltd. Tianjin
Nantong City Yojo Medical Products Co., Ltd. Jiangsu, contract manufacturer
Ningbo Hanyue Medical Technology Co., Ltd. Zhejiang, contract manufacturer
Planet(Shanghai) International Co., Ltd. Shanghai
Taizhou Chenguang Import AND Export Trading Co., Ltd. Jiangsu
Taizhou Xinkang Medical Materials Co., Ltd. Jiangsu, contract manufacturer
Trummed Medical (Hangzhou) Co., Ltd. Zhejiang, contract manufacturer
Wuxi Xindi Medical Technology Co., Ltd. Jiangsu
Xiamen Firstcare IMP. & EXP. Co., Ltd. Fujian
Xinhua Surgical Instrument Co., Ltd. Shandong
Zhejiang Longmed Medical Technology Co., Ltd. Zhejiang

What Is FDA Product Code FZQ?

Clip, Removable (Skin) is FDA product code FZQ, Class 1, 21 CFR 878.4320.

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.

Clip, Removable (Skin)