Device, Paste-On for Incontinence, Non-Sterile

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are concentrated in Jiangsu, Guangdong and Fujian, and 3 other provinces: 13 hold an FDA registration. 4 are contract manufacturers.

Boen Healthcare Co., Ltd. Jiangsu
Conod Medical Shuyang Co., Ltd. Jiangsu, contract manufacturer
Conod Medical Co., Limited Jiangsu, contract manufacturer
Foshan OST Medical Equipment Technology Co., Ltd. Guangdong, contract manufacturer
Foshan Zubon Technology Co., Ltd. Guangdong
Fujian Hui'an Hecheng Household Products Co., Ltd. Fujian
Hangzhou Primecare Medical Co., Ltd. Zhejiang, contract manufacturer
Jiangsu NEW Pentastar Medical Products Co., Ltd. Jiangsu
Jiangsu JianYu Health Medical Co., Ltd. Jiangsu, contract manufacturer
Primecare Medical (Suzhou) Co., Ltd. Jiangsu, contract manufacturer
Sunshine Healthcare Co., Ltd. Guangdong
Tuper Medical Co., Ltd. Shandong
Ucomfor Medical Co., Ltd. Shanghai

What Is This Device?

Urine collector and accessories; see product code EXI.

How Is NOA Classified?

Device, Paste-On For Incontinence, Non-Sterile is FDA product code NOA, Class 1, 21 CFR 876.5250.

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.

Device, Paste-On For Incontinence, Non-Sterile