Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
Who Makes This Device Type in China?
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?
A subcutaneous factory calibrated, non-adjunctive, invasive, passive monitoring glucose sensor is intended to determine glucose levels and the direction and rate of change of glucose levels in people with diabetes. Calibrated at the point of manufacture and does not require or accept any user-entered calibration. Monitors glucose levels passively and only provides information, including alarms and alerts, in response to a user initiated action.
The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions and also provides historical glucose information, facilitating long-term therapy adjustments.
How Is PZE Classified?
Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated is FDA product code PZE, Class 3.
How Does It Reach the US Market?
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 Do the Recalls Say?
The FDA has recorded 3 recalls under this product code since 2021. None was by a company in China. 2 are Class I, the most serious grade.
The root causes the FDA records most often are Device Design (2) and Environmental control (1). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.