Needle, Cerclage, Gynecological
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are based in Jiangsu and Shandong: 2 hold an FDA registration.
- Hospital & Homecare IMP. & EXP. Co., Ltd. Jiangsu, contract manufacturer
- Xinhua Surgical Instrument Co., Ltd. Shandong
How Is HDH Classified?
Needle, Cerclage, Gynecological is FDA product code HDH, Class 1, 21 CFR 884.4530.
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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