Collimator, X-Ray
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are based in Shanghai and Jiangsu: 3 hold an FDA registration. 1 is a contract manufacturer.
- Shanghai Lions Industrial Co., Ltd. Shanghai, contract manufacturer
- Shanghai Jolly Industrial Co., Ltd. Shanghai, contract manufacturer
- iBrite Suzhou Technology Co., Ltd. Jiangsu, contract manufacturer
What Is FDA Product Code EHB?
Collimator, X-Ray is FDA product code EHB, Class 1, 21 CFR 872.1840.
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.
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