Clamp and Cutter, Umbilical
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are concentrated in Zhejiang, Guangdong and Jiangsu: 4 hold an FDA registration.
- Boen Healthcare Co., Ltd. Jiangsu
- Hantech Medical Device Co., Ltd. Zhejiang, contract manufacturer
- Ningbo Greetmed Medical Instruments Co., Ltd. Zhejiang
- Zhuhai DR Medical Instruments Co., Ltd. Guangdong
What Is FDA Product Code NBZ?
Clamp And Cutter, Umbilical is FDA product code NBZ, Class 2, 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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