Applicator for Rectal Suppository
Who Makes This Device Type in China?
2 manufacturers in China hold an FDA registration for this device type, based in Guangdong and Jiangsu. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.
- Jiangsu Hanheng Medical Technology Co., Ltd. Jiangsu, contract manufacturer
- Shun SZE Industrial (Shenzhen) Co., Ltd. Guangdong, contract manufacturer
What Is This Device?
Intended for use in the insertion of suppositories into the rectum
What Is FDA Product Code OOW?
Applicator For Rectal Suppository is FDA product code OOW, Class 1, 21 CFR 876.4730.
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.