Global Scientific Technologies, LLC

Global Scientific Technologies, LLC specializes in haemodialysis concentrate products. These include liquid and powder formulations designed to acidify or provide bicarbonate for renal dialysis systems. Examples include citric acid-based concentrates, acetic acid or sodium diacetate-based concentrates, bicarbonate concentrates, and acetate-based concentrates with sodium acetate. These products are formulated to be compatible with dialysis machines and support the treatment process for patients with kidney failure.

The company is headquartered in the United States. Its location ensures compliance with US regulatory standards, which govern the design, manufacturing, and distribution of its medical devices.

The company’s devices are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identification (UDI) system. These registries track medical devices that have undergone the necessary regulatory pathways to demonstrate substantial equivalence to legally marketed predicates or compliance with applicable performance standards.

Global Scientific Technologies, LLC’s haemodialysis concentrates are classified as Class II medical devices under US regulations. This classification is based on the FDA’s risk-based categorization system, where Class II devices require special controls in addition to general controls to ensure their safety and effectiveness. These controls may include performance standards, post-market surveillance, or patient-specific device labeling.