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AccuBioTech Has Got the Renewed EN ISO 13485:2016 Certificate

Jul. 14, 2020

AccuBioTech Co., Ltd. has established and applies a quality management system for medical devices for the following scope:

Design and Development, Manufacture and Distribution of In-Vitro Diagnostic Analyzers, In-Vitro Diagnostic Test Kits used in the Detection of Cancer, Cardiac Markers, Disease Status, Drug of Abuse, Fertility Testing, Pregnancy Testing including Home Use In-vitro Diagnostic Devices.


The quality management is subjected to yearly surveillance.


On Apr. 27-28, 2020, a surveillance audit of our quality management system was performed by an audit team from TUV Rheinland LGA Products GmbH. Proof has been furnished that the requirements specified in EN ISO 13485:2016 are fulfilled. The audit team confirmed that our quality management system is applied effectively with respect to the requirements of EN ISO 13485:2016.


Certificate Registration No.: SX 60149280 0001;

Effective Date: 2020-07-16;

This Certificate is valid until: 2023-07-15.