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GenSure Biotech Inc.

GenSure Biotech Inc.,founded in Shanghai in 2014,is a high-tech company specializing in the R&D,manufacturing,and distribution of in vitro diagnostic(IVD) reagents and instruments.We offer rapid test kits for infectious diseases (respiratory,gastrointestinal,STIs,tropical disease),bacterial vaginitis and fertility hormones,as well as fluorescence immunoassay quantitative assays and multi-pathogen combo panels.Our products are CE-marked and globally sold.We also provide flexible OEM/ODM services.With automation,QC,and regulatory expertise,GenSure offers affordable,scalable diagnostic solutions.

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News

GenSure Biotech Secures CE IVDR Certification for Four At-Home Rapid Test Kits, Marking a New Chapter in Globalization Strategy

2025

08-22

GenSure Biotech Secures CE IVDR Certification for Four At-Home Rapid Test Kits, Marking a New Chapter in Globalization Strategy

[Beijing, China — Date] – GenSure Biotech Inc. today reached a significant milestone as four of its at-home rapid diagnostic test kits — Strep A, LH Ovulation, HCG Pregnancy, and Flu A+B — have simultaneously obtained EU CE IVDR certification. This achievement not only serves as solid proof of product excellence but also marks a critical step forward in the company’s globalization strategy.

2025

08-20

Good News! GenSure FOB-Fecal Occult Blood Rapid Test Approved by MOH Indonesia

2022

12-15

Statement

2022

11-02

GenSure to Attend Medica in Düsseldorf