Micro Mixer
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are based in Jiangsu: 2 hold an FDA registration.
How Is JRB Classified?
Micro Mixer is FDA product code JRB, Class 1, 21 CFR 862.2050.
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.
What Has Gone Wrong With It?
The FDA has recorded 1 recall under this product code since 2013. None was by a company in China. The root cause the FDA records most often is Nonconforming Material/Component (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
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