Anesthesiology › Monitoring

Which Manufacturers in China Work in This Section?

59 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Jiangsu, Guangdong and Zhejiang, and 7 other provinces. 22 of them are contract manufacturers. Chinese manufacturers are registered for 17 of 34 device types here.

11 of those 17 device types need no premarket submission before sale in the United States. The FDA has recorded 84 recalls across the section’s product codes; the root causes it names most often are Device Design (15), Nonconforming Material/Component (14) and Component design/selection (14).

The Largest Device Types Made in China

The device types with the most Chinese manufacturers are Regulator, Pressure, Gas Cylinder (27), Cylinder, Compressed Gas, And Valve (9), Flowmeter, Tube, Thorpe, Back-Pressure Compensated (9), Monitor, Breathing Frequency (8) and Monitor, Airway Pressure (Includes Gauge And/Or Alarm) (7). All 17 device types in this section with a Chinese manufacturer, most manufacturers first:

Regulator, Pressure, Gas Cylinder 27 manufacturers
Cylinder, Compressed Gas, And Valve 9 manufacturers
Flowmeter, Tube, Thorpe, Back-Pressure Compensated 9 manufacturers
Monitor, Breathing Frequency 8 manufacturers
Monitor, Airway Pressure (Includes Gauge And/Or Alarm) 7 manufacturers
Flowmeter, Calibration, Gas 5 manufacturers
Stimulator, Nerve, Peripheral, Electric 5 manufacturers
Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge 3 manufacturers
Ventilatory Effort Recorder 3 manufacturers
Gauge, Gas Pressure, Cylinder/Pipeline 2 manufacturers
Stimulator, Nerve, Battery-Powered 2 manufacturers
Monitor, Carbon-Dioxide, Cutaneous 1 manufacturer
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia 1 manufacturer
Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia 1 manufacturer
Transducer, Gas Flow 1 manufacturer
Transducer, Gas Pressure 1 manufacturer
Transducer, Gas Pressure, Differential 1 manufacturer

Flowmeter, Calibration, Gas

Anesthesiology › Monitoring

Which Manufacturers in China Work in This Section?

The Largest Device Types Made in China

Dial Flowmeter

SleepmateThermocouple Airflow – 90 Cm

SleepmateThermistor AirFlow – 90 Cm

Digi-Flo Pkg C, W Sec. Desk Alarm -NP

FRU, N2O Shut off Valve W Gauge

Where China Actually Supplies