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ISO 13485:2016

New Gene (Hangzhou)
Bioengineering Co., Ltd.
Room 1606, 16th Floor, No.5 Building
688 Bin'an Road
Hangzhou
Binjiang District
310052
China

Certificate Number: MD 729179
Scope: Design, development, manufacture and distribution of in-vitro diagnostic rapid test kits for drugs of abuse and detection of infectious diseases.
药物滥用和传染病的体外诊断快速检测试剂盒的设计、开发、制造和销售。

Original Registration Date	Effective Date	Last Revision Date	Expiry Date
2020-07-27	2023-07-27	2024-05-20	2026-07-26

Site Name	Site Address	Certificate/License number	Standard/Scheme number or name
New Gene (Hangzhou) Bioengineering Co., Ltd.	Room 1606, 16th Floor, No.5 Building 688 Bin'an Road Binjiang District Hangzhou China	MD 729179	ISO 13485:2016