ATCOR MEDICAL PTY LTD

ATCor Medical specializes in portable electronic blood pressure monitors that automatically inflate and can be used on either the arm or wrist. Additionally, they produce modular patient monitoring systems designed for multifunctional use, such as measuring pulse and analyzing waveforms. These devices are tailored for clinical and home monitoring applications.

ATCor Medical is based in the United States. While the company’s location influences its regulatory obligations—such as compliance with FDA requirements—it does not inherently determine whether its devices are authorized. Individual devices must undergo their own regulatory processes, such as FDA clearance or classification, to meet market authorization criteria.

ATCor Medical’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry helps track and identify medical devices in the U.S. market, ensuring transparency and traceability for healthcare providers and regulators.

ATCor Medical’s devices fall under Class II regulatory classification. This classification typically applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as blood pressure monitors and patient monitoring systems. The classification determines the regulatory pathway and scrutiny required for market authorization.