WWHS Biotech.Inc

WWHS Biotech Inc specializes in in vitro diagnostic devices, including both test kits and analyzers. Their products cover immunochromatographic assays for detecting substances like fecal occult blood, transferrin, and serum markers such as amyloid A, D-dimer, and growth stimulation expressed gene 2. They also develop rapid quantitative fluorescence immunoassays for hormones and vitamins, such as estradiol, free thyroxine, and 25-hydroxyvitamin D. Additionally, the company produces automated diagnostic equipment like a fully auto hematology analyzer and a dry biochemistry immunoassay analyzer.

WWHS Biotech Inc is based in China. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites may vary.

WWHS Biotech Inc’s devices are registered in the EU’s eudamed database, which is the official European Union registry for medical devices. This registry tracks manufacturers and their products to ensure transparency and compliance within the European market.

WWHS Biotech Inc’s devices fall under two primary classifications: Class A (typically for low-risk diagnostic tests) and In Vitro Diagnostic (IVD) General (a broader category for diagnostic devices not fitting into specific risk classes). Classification is determined by factors like the intended use, potential health risks, and the nature of the test, ensuring appropriate regulatory oversight.