Obstetrics & Gynecology › Monitoring

Which Manufacturers in China Work in This Section?

23 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Guangdong, Anhui and Jiangsu, and 4 other provinces. 3 of them are contract manufacturers. Chinese manufacturers are registered for 9 of 40 device types here.

1 of those 9 device types need no premarket submission before sale in the United States. The FDA has recorded 56 recalls across the section’s product codes; the root causes it names most often are Device Design (15), No Marketing Application (7) and Process design (4).

The Largest Device Types Made in China

The device types with the most Chinese manufacturers are Monitor, Ultrasonic, Fetal (13), System, Monitoring, Perinatal (6), Stethoscope, Fetal (4), Monitor, Uterine Contraction, External (For Use In Clinic) (2) and Transducer, Pressure, Intrauterine (2). All 9 device types in this section with a Chinese manufacturer, most manufacturers first:

Monitor, Ultrasonic, Fetal 13 manufacturers
System, Monitoring, Perinatal 6 manufacturers
Stethoscope, Fetal 4 manufacturers
Monitor, Uterine Contraction, External (For Use In Clinic) 2 manufacturers
Transducer, Pressure, Intrauterine 2 manufacturers
Transducer, Ultrasonic, Obstetric 2 manufacturers
Monitor, Blood-Flow, Ultrasonic 1 manufacturer
Monitor, Heart Rate, Fetal, Non-Stress Test (Home Use) 1 manufacturer
Uterine Electromyographic Monitor 1 manufacturer

Uterine Electromyographic Monitor

Monica

Monica Interface CTG Cable - GE Corometrics FECG green rectangular connector

Transducer, Ultrasonic, Obstetric

2.30MHZ OB Probe

Catalogue number 832-6230-11, listed by Parks Medical Electronics, Inc., United States, under Transducer, Ultrasonic, Obstetric. 2 manufacturers in China are registered for this product code.

System, Monitoring, Perinatal

FC1400

System, Monitoring, Perinatal

Transducer, Ultrasonic, Obstetric

2.20MHZ OB Probe

Catalogue number 832-6220-11, listed by Parks Medical Electronics, Inc., United States, under Transducer, Ultrasonic, Obstetric. 2 manufacturers in China are registered for this product code.

Monitor, Blood-Flow, Ultrasonic

8.0 MHz Sterilizable Superficial Vascular Probe

Catalogue number TSP-8S, listed by Coopersurgical, Inc., United States, under Monitor, Blood-Flow, Ultrasonic. 1 manufacturer in China is registered for this product code.

Monitor, Blood-Flow, Ultrasonic

E-ST Pro

Catalogue number 60132PRO8, listed by Avante, under Monitor, Blood-Flow, Ultrasonic. 1 manufacturer in China is registered for this product code.

Monitor, Uterine Contraction, External (For Use In Clinic)

Avalon CL Fetal & Maternal Pod

The Avalon CL Fetal & Maternal Pod enables the Avalon wearable solution. It is used together with the Avalon CL Basestation 866074.

System, Monitoring, Perinatal

Advanced Central Monitoring Station

The Advanced CMS-1000FM Central Monitoring Station manages perinatal monitoring data before and during labour in healthcare facilities. It brings data from bedside fetal and maternal…

System, Monitoring, Perinatal

Cetro America Toco Transducer for IM76/AM66, Waterproof

Replacement Waterproof Toco Transducer for Advanced Medical Systems/Spacelabs Medical model IM76/AM66 fetal monitors.

System, Monitoring, Perinatal

Cetro America Ultrasound Transducer for Coro 115&145, Waterproof

Replacement Waterproof Ultrasound Transducer for Corometrics 115&145 model fetal monitors.

Transducer, Ultrasonic, Obstetric

Avalon Ultrasound Transducer USA

Avalon US Transducer USA

System, Monitoring, Perinatal

Avalon Fetal Monitor FM40

Avalon FM40 Fetal Monitor for external Fetal Monitoring

Transducer, Ultrasonic, Obstetric

2.25MHZ OB Probe

Catalogue number 832-6225-11, listed by Parks Medical Electronics, Inc., United States, under Transducer, Ultrasonic, Obstetric. 2 manufacturers in China are registered for this product code.

Monitor, Ultrasonic, Fetal

Neonatal

Fetal Doppler

System, Monitoring, Perinatal

Cetro America Ultrasound Transducer for IM76/AM66, Waterproof

Waterproof Ultrasound Transducer for Advanced Medical Systems/SpaceLabs medical IM76/AM66 model fetal monitors.

Monitor, Blood-Flow, Ultrasonic

Tria II

Doppler Probe; 5 MHz Interchangeable Model

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer