BLOOD TEST STRIPS CONTROLS

Primary DI

D-01A0104XW

Basic UDI-DI Code

B-01A0104XW

Reference

2J003; 2J004; 2K002; 2K003

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd Annex 2 List B

Status

On The Market

Manufacturer

Changsha Sinocare Inc.

The Safe AQ Smart, Safe AQ Air, Safe AQ Voice Blood Glucose Monitoring System is designed for the quantitative measurement of glucose in fresh capillary whole blood taken from the fingertip or in venous whole blood samples, The Blood Glucose Monitoring System is for use outside the body only (in vitro diagnostic use) for self-testing and professional use as an aid in the management of diabetes. It is for in vitro diagnostic use only and should not be used for the diagnosis or screening of diabetes.

Other on-the-market devices with the same classification (Eu Ivd Annex 2 List B) and regulation (EU IVDD).