Which Manufacturers in China Work in This Section?
71 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Zhejiang, Jiangsu and Guangdong, and 9 other provinces. 9 of them are contract manufacturers. Chinese manufacturers are registered for 26 of 79 device types here.
22 of those 26 device types need no premarket submission before sale in the United States. The FDA has recorded 393 recalls across the section’s product codes; the root causes it names most often are Software design (48), Nonconforming Material/Component (30) and Storage (29).