Weihai Kangzheng Medical Equipment Technology Co., Ltd

Weihai Kangzheng Medical Equipment Technology Co., Ltd specializes in in vitro diagnostic (IVD) devices, specifically urinalysis strips. These strips are designed to detect multiple urine analytes, such as glucose, ketones, protein, blood, pH, and specific gravity, enabling rapid point-of-care testing for clinical or home use. The focus is on providing quick assessments of urinary health indicators.

The company is based in the United States. This location influences its regulatory compliance, as its devices must adhere to U.S. regulatory requirements, including those set by the FDA.

The company’s devices, including urinalysis strips, are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps ensure traceability and transparency of medical devices authorized for use in the U.S.

The urinalysis strips manufactured by Weihai Kangzheng Medical Equipment Technology Co., Ltd fall under Class I regulatory classification in the U.S. This classification applies to devices deemed to pose minimal risk, often requiring only general controls to ensure safety and effectiveness. The classification is determined by the FDA based on factors like the device’s intended use and potential health impact.