Sensor, Glucose, Invasive
Which Manufacturers in China Make This?
One manufacturer in China holds an FDA registration for this device type, based in Guangdong. All of them are contract manufacturers, able to build to a buyer’s own specification.
- Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd. Guangdong, contract manufacturer
What Is This Device?
The device is a glucose-monitoring device indicated for detecting trends and tracking patterns in adults (age 18 and older) with diabetes. The device is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The system aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.
What Is FDA Product Code MDS?
Sensor, Glucose, Invasive is FDA product code MDS, Class 3.
What Does It Take to Sell It in the United States?
A premarket approval is required: the Class 3 route, granted on clinical evidence rather than on equivalence to an existing device. No approval under this code names a Chinese applicant.
What Has Gone Wrong With It?
The FDA has recorded 57 recalls under this product code since 2008. None was by a company in China. 6 are Class I, the most serious grade.
The root causes the FDA records most often are Process control (20), Device Design (8) and Software design (5). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.