Cable

Who Makes This Device Type in China?

2 manufacturers in China hold an FDA registration for this device type, based in Guangdong and Hebei. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.

Amphenol Medical Technologies (Dongguan) Co., Ltd. Guangdong, contract manufacturer
Debo Medical Technology (Shijiazhuang) Co., Ltd. Hebei, contract manufacturer

How Is ISN Classified?

Cable is FDA product code ISN, Class 1, 21 CFR 890.3420.

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.

Cable