Which Manufacturers in China Work in This Section?
18 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Zhejiang, Guangdong and Jiangsu, and 9 other provinces. Chinese manufacturers are registered for 19 of 144 device types here. None of those device types needs a premarket submission before sale in the United States.
The FDA has recorded 139 recalls across the section’s product codes; the root causes it names most often are Nonconforming Material/Component (17), Process control (12) and Storage (7).