Clinical Chemistry › Laboratory Instruments

Who Makes It in China?

191 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Guangdong, Jiangsu and Zhejiang, and 18 other provinces. 27 of them are contract manufacturers. Chinese manufacturers are registered for 47 of 91 device types here.

None of those device types needs a premarket submission before sale in the United States. The FDA has recorded 1,113 recalls across the section’s product codes; the root causes it names most often are Software design (316), Device Design (127) and Nonconforming Material/Component (108).

The Largest Device Types Made in China

The device types with the most Chinese manufacturers are Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use (72), Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use (37), Micro Pipette (29), Clinical Sample Concentrator (27) and Unit, Filter, Membrane (17). All 47 device types in this section with a Chinese manufacturer, most manufacturers first:

Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 72 manufacturers
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use 37 manufacturers
Micro Pipette 29 manufacturers
Clinical Sample Concentrator 27 manufacturers
Unit, Filter, Membrane 17 manufacturers
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 16 manufacturers
Automated Urinalysis System 16 manufacturers
Real Time Nucleic Acid Amplification System 15 manufacturers
Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis) 14 manufacturers
Colorimeter, Photometer, Spectrophotometer For Clinical Use 13 manufacturers
Shaker/Stirrer 13 manufacturers
Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use 9 manufacturers
Instrumentation For Clinical Multiplex Test Systems 9 manufacturers
Mixer, Blood Tube 8 manufacturers
Refractometer For Clinical Use 8 manufacturers
Blender/Mixer 7 manufacturers
Calculator/Data Processing Module, For Clinical Use 7 manufacturers
Block, Heating 6 manufacturers
Papers, Ion 6 manufacturers
Unit, Drying 6 manufacturers
Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate 5 manufacturers
Fluorometer, For Clinical Use 5 manufacturers
Freezer 5 manufacturers
Station, Pipetting And Diluting, For Clinical Use 5 manufacturers
Thermocycler, Generic 5 manufacturers
Timer, General Laboratory 5 manufacturers
Apparatus, Electrophoresis, For Clinical Use 4 manufacturers
Cuvette, Thermostated 4 manufacturers
Electrode, Ion Selective (Non-Specified) 4 manufacturers
Evaporator 4 manufacturers
Osmometer For Clinical Use 4 manufacturers
Analyzer, Chemistry, Centrifugal, For Clinical Use 3 manufacturers
Analyzer, Chemistry, Micro, For Clinical Use 3 manufacturers
Analyzer, Enzyme, For Clinical Use 3 manufacturers
Instrumentation, High Pressure Liquid Chromatography 3 manufacturers
Ph Meter 3 manufacturers
Regulator, Temperature 3 manufacturers
U.V. Light, Tlc 3 manufacturers
Chromatography (Liquid, Gel), Clinical Use 2 manufacturers
Mass Spectrometer, Clinical Use 2 manufacturers
Micro Mixer 2 manufacturers
Nephelometer, For Clinical Use 2 manufacturers
Data Acquisition Software 1 manufacturer
Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica 1 manufacturer
Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System 1 manufacturer
Droplet Digital Pcr System 1 manufacturer
Microtitrator, For Clinical Use 1 manufacturer

Real Time Nucleic Acid Amplification System

Clinical Chemistry › Laboratory Instruments

Who Makes It in China?

The Largest Device Types Made in China

Where China Actually Supplies