Hematology › Manual Hematology Devices

Which Manufacturers in China Work in This Section?

49 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Zhejiang, Jiangsu and Shandong, and 10 other provinces. 9 of them are contract manufacturers. Chinese manufacturers are registered for 11 of 26 device types here.

8 of those 11 device types need no premarket submission before sale in the United States. The FDA has recorded 61 recalls across the section’s product codes; the root causes it names most often are Process change control (13), Process control (5) and Material/Component Contamination (4).