Blood Glucose Monitoring System

Primary DI

06939184631578

Basic UDI-DI Code

B-06939184631578

Reference

G-425-3

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd Annex 2 List B

Status

On The Market

Manufacturer

Bioland Technology Ltd.

The Blood Glucose Monitoring System manufactured by Bioland Technology Ltd. (hereafter referred to asBioland) mainly consists of blood glucose meter, blood glucose test strips and control solution. The bloodglucose meter is active and only for single patient use. The blood glucose test strips are single-use and contain GOD (glucose oxidase), which is a biological product produced by the fermentation of the microorganism Aspergillus niger. The control solution is precisely formulated solutions with known blood glucose concentrations, typically measured in millimoles per liter (mmol/L) or milligrams per deciliter(mg/dL). (Accessory:Test strip:50 pcs;Sterile lancet:50 pcs;Lancing device:1 pcs)

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