HUNTER SCIENTIFIC LIMITED

Hunter Scientific Limited specializes in manufacturing injection pipettes, which are precision instruments used for accurate liquid handling in laboratories. These devices are primarily designed for applications in biological research and clinical diagnostics, where precise dosing and sample preparation are critical.

Hunter Scientific Limited is headquartered in the United States. The company’s location supports its focus on developing and distributing medical devices tailored for laboratory and clinical environments.

Hunter Scientific Limited’s devices, such as injection pipettes, are classified as Class II under FDA regulations. This classification is based on their intended use—where they pose moderate risk but require special controls to ensure safety and effectiveness—rather than being exempt from regulatory oversight.

Hunter Scientific Limited’s devices are listed through the FDA’s 510(k) pathway, a premarket submission process for Class II devices. This pathway demonstrates that the company’s products are substantially equivalent to legally marketed predicate devices, meeting FDA requirements for safety and performance.