Trocar, Tracheal
Who Makes This Device Type in China?
3 manufacturers in China hold an FDA registration for this device type, based in Jiangsu and Zhejiang.
- Boen Healthcare Co., Ltd. Jiangsu
- Hangzhou Ruihao Medical Technology Ltd Zhejiang, contract manufacturer
- Huaian Angel Medical Instrument Co., Ltd. Jiangsu
How Is KCI Classified?
Trocar, Tracheal is FDA product code KCI, Class 1, 21 CFR 874.4420.
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.
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