Barium Enema Kit
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are based in Guangdong and Shanghai: 2 hold an FDA registration. 1 is a contract manufacturer.
- Cixi Qimei Combination Tool Packing Factory Shanghai, contract manufacturer
- Dongguan Junhai Medical Device Co., Ltd. Guangdong, contract manufacturer
What Is It?
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
What Is FDA Product Code FCD?
Barium Enema Kit is FDA product code FCD, Class 1, 21 CFR 876.5210.
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.