Hudson RCI
2 catalogue numbers from IPN039380, listed by Teleflex Medical LLC, United States, under Board, Cardiopulmonary. 5 manufacturers in China are registered for this product code.
Board, Cardiopulmonary
Who Makes This Device Type in China?
5 manufacturers in China hold an FDA registration for this device type, based in Jiangsu.
- Dragon Medical Co., Ltd. Jiangsu, contract manufacturer
- Jiangsu Rixin Medical Equipment Co., Ltd. Jiangsu
- Zhangjiagang Jiekang Medical Equipment Co., Ltd. Jiangsu
- Zhangjiagang NEW Fellow MED Co., Ltd. Jiangsu
- ZJG Royaltrust MED Co., Ltd. Jiangsu, contract manufacturer
How Is FOA Classified?
Board, Cardiopulmonary is FDA product code FOA, Class 1, 21 CFR 880.6080.
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.
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