Sinocare Inc.

三诺生物传感股份有限公司

Sinocare was founded in Changsha, Hunan in 2002 and is China's first listed blood glucose meter company (SZSE: 300298). It reports being China's No.1 and the world's No.4 blood glucose monitoring company, with 9 global R&D and manufacturing sites, 187 countries and regions served, over 25 million users and 780+ authorised patents. Its portfolio spans blood glucose meters and strips, continuous glucose monitoring, uric acid, HbA1c and point-of-care analysers.

FDA 510(k) K170264 - Gold AQ Blood Glucose Monitoring System (Changsha Sinocare, Inc., 2017-10-05)FDA 510(k) K231476 - TRUENESS AIR / TRUENESS Blood Glucose Monitoring System (Sinocare, Inc., 2023-12-01)ISO 13485 (TUV) and CE certificate stated on the official Sinocare company/store pages (not independently verified in an EU database)

1 listed product

Sinocare Gold AQ Plus Blood Glucose Monitoring System

Medical Devices & Health Equipment

Sinocare Inc.

Sinocare Gold AQ Plus Blood Glucose Monitoring System

FDA-cleared gold-electrode glucose system: 0.8 uL sample, 5-second results

IVD Analyser
FDA 510(k) K170264 - Gold AQ Blood Glucose Monitoring System platform clearance (Changsha Sinocare, Inc., 2017); Plus-specific 510(k) coverage was not separately confirmed · EN ISO 15197:2015 (per official Sinocare product page)
MOQ 100 pieces (per the manufacturer's own storefront listing for the Gold AQ Plus kit)

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