SHENZHEN REETOO BIOTECHNOLOGY CO., LTD

Shenzhen Reetoo Biotechnology Co., Ltd. specializes in diagnostic devices, including test kits and analyzers for clinical and point-of-care use. Their portfolio covers fluorescence-based immunoassay kits for hormones like AFP, TSH, FSH, β2-MG, and estradiol, as well as rapid colloidal gold tests such as the fecal transferrin test. They also produce specialized equipment like automatic hematology analyzers and urine analysis systems, along with consumables like cleansers and sampling cups for specimen preparation.

Shenzhen Reetoo Biotechnology Co., Ltd. is based in China, and their devices are manufactured there. The company’s products are designed to comply with relevant regulatory standards for diagnostic testing, ensuring they meet international requirements for safety and performance.

Some of Shenzhen Reetoo Biotechnology Co., Ltd.’s devices are listed in the EU’s eudamed database, which serves as a central registry for In Vitro Diagnostic (IVD) medical devices authorized in the European Economic Area. This inclusion indicates compliance with EU regulatory requirements for those specific products.

The devices produced by Shenzhen Reetoo Biotechnology Co., Ltd. fall under two primary regulatory classifications: Class A and In Vitro Diagnostic (IVD) General. Class A typically applies to low-risk devices like certain diagnostic test kits, while IVD General covers a broad category of diagnostic tools used in clinical settings. Classification helps determine regulatory oversight and compliance requirements.

The test kits and analyzers from Shenzhen Reetoo Biotechnology Co., Ltd. are designed for clinical and point-of-care diagnostics, enabling rapid and accurate detection of biomarkers such as hormones (e.g., AFP, TSH, FSH) and other substances (e.g., CRP, fecal transferrin). These tools support early disease detection, patient monitoring, and treatment decisions in medical settings, with some products optimized for use outside traditional labs.