Gmate® Blood Glucose Test Strips

Primary DI

08809301168486

Basic UDI-DI Code

B-08809301168486

Reference

PS004-INT

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd Annex 2 List B

Status

On The Market

Manufacturer

GB Lifecare Co., Ltd.

The Blood Glucose Monitoring System for self-testing is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood or venous blood with the Blood Glucose Test Strip. The Blood Glucose Monitoring System is intended for self-testing use outside the body (for in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Blood Glucose Monitoring System should not be used for the diagnosis of diabetes or testing of newborns. The Blood Glucose Test Strip is part of Blood Glucose Monitoring System. It is used to draw the blood and perform chemical reaction of glucose oxidase and blood glucose. Components ① Test Strips ② Insert

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