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SIBIONICS Achieves Milestone: Receiving CE Mark for Its Groundbreaking GS1 Continuous Glucose Monitoring System

PRNewswire November 1, 2023

SHENZHEN, China, Nov. 1, 2023 /PRNewswire/ — SIBIONICS, the world’s third-largest Continuous Glucose Monitoring System (CGM) brand, is delighted to announce that it has received the CE Mark for its revolutionary GS1 CGM. This significant milestone marks a momentous achievement for SIBIONICS, facilitating the distribution and utilization of this game-changing technology throughout the European market.

The CE Mark, also known as the “Conformité Européene” or European Conformity, is a certification that confirms a product’s compliance with European Union (EU) health and safety standards, serving as proof of the products’ quality, safety, and efficacy.

Founded in 2015, SIBIONICS boasts a workforce exceeding 700 individuals, with over 40% actively engaged in research and development efforts. To date, SIBIONICS has collaborated with 1,600 hospitals on integrating the GS1 CGM for inpatient treatment, benefiting over 600,000 users worldwide in managing their diabetes. With an annual production capacity of 6,000,000 units and consistently achieving a low MARD value of 8.83% in each batch, SIBIONICS is well-equipped to serve a larger customer base.

At its core, the SIBIONICS GS1 CGM System is designed to empower both healthcare professionals and patients with the information needed to make informed treatment decisions and maintain optimal glucose control.

The SIBIONICS GS1 CGM offers users 14 days of calibration-free continuous glucose monitoring solution, empowering them with the capability to transmit glucose data to their monitoring devices or mobile applications and generate professional AGP reports. To assist users in better diabetes management, the GS1 CGM also facilitates data sharing with friends and family while seamlessly integrates the latest ProView remote access platform. This equips healthcare providers with the ability to monitor remotely and deliver timely medical interventions as needed.

As an innovative MedTech company that combines medical technology with artificial intelligence, SIBIONICS is committed to extending their innovative and groundbreaking diabetes management technology and expertise to more diabetes patients worldwide.

Simultaneously, SIBIONICS is vigorously expanding its presence in various specialized segments within the area of health management. Their successful launch of the consumer-grade biowearable – the KS1 Continuous Ketone Monitoring System(CKM), has garnered enthusiastic acclaim from consumers.

Starting today, SIBIONICS GS1 CGM products will gradually become available for pre-sales in EU countries, the UK, and other European countries. Those interested can find more information on official website at www.sibionicscgm.com.

Sandra Zhang


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