Merlin Biomedical (Xiamen) Co., Ltd.

Merlin Biomedical (Xiamen) Co., Ltd. specializes in in vitro diagnostic (IVD) devices, specifically SARS-CoV-2 antigen rapid test cassettes. These devices are designed for self-testing, allowing users to detect the presence of the virus at the point of care, such as at home or in non-clinical settings.

The company is headquartered in China. This location reflects its operational base for research, development, and manufacturing of its diagnostic devices.

Yes, Merlin Biomedical’s IVD devices are registered in the EU’s eudamed database. This registry is used to track and provide transparency on medical devices authorized for use within the European Economic Area, ensuring compliance with regulatory requirements.

Merlin Biomedical’s devices, such as the SARS-CoV-2 antigen rapid test cassettes, are classified as in vitro diagnostic (IVD) devices for self-testing. This classification is important because it determines the regulatory pathway and requirements for authorization, ensuring they meet safety, performance, and usability standards for direct use by individuals without professional medical supervision.