Illuminator, Radiographic-Film
Who Makes This Device Type in China?
5 manufacturers in China hold an FDA registration for this device type, concentrated in Guangdong, Jiangsu and Anhui.
- Danyang NEW Hope Medical Equipment Co., Ltd. Jiangsu
- Guangdong Yuehua Medical Instrument Factory Co., Ltd. Guangdong, contract manufacturer
- Hefei MT Medical Co., Ltd. Anhui
- Jiangsu Keling Medical Appliances Co., Ltd. Jiangsu, contract manufacturer
- Lakong Medical Devices Co., Ltd. Guangdong
What Is FDA Product Code IXC?
Illuminator, Radiographic-Film is FDA product code IXC, Class 1, 21 CFR 892.1890.
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.