Hangzhou Bosure Biotech Co., Ltd

Hangzhou Bosure Biotech Co., Ltd manufactures in vitro diagnostic test strips and devices for urinalysis, hemoglobin measurement, uric acid testing, fecal occult blood detection, lipid analysis, and renal function assessment. Their products include urine adulteration test strips, hemoglobin test strips and microcuvettes, uric acid test strips, fecal occult blood rapid test devices, urine and lipid control solutions, renal function test devices, urinalysis reagent strips, lipid test devices, urine analyzers, and hemoglobin testing systems.

Hangzhou Bosure Biotech Co., Ltd is based in China, as indicated by the country code CN in the provided data. The company’s location is specified within the device data summary, which confirms its operational base in China without referencing any additional details about facilities, staff, or history.

The devices manufactured by Hangzhou Bosure Biotech Co., Ltd are listed in the EUDAMED database, as explicitly stated in the DEVICE_DATA section under 'LISTED IN: eudamed'. This indicates that the company’s devices are registered in the European Union’s medical device database for transparency and traceability purposes.

The devices of Hangzhou Bosure Biotech Co., Ltd are classified as Class A IVD General under the applicable regulatory framework. This classification is directly stated in the DEVICE_DATA section and reflects the risk level assigned to these in vitro diagnostic products, with Class A representing the lowest risk category for IVDs under regulations such as the EU IVDR.