Medifactia AB

Medifactia AB specializes in ingestible radiological image markers, specifically designed to improve visibility during imaging procedures. Their primary product, Transit-Pellets, is used to enhance the tracking and localization of gastrointestinal transit in medical imaging studies, ensuring clearer visualization for diagnostic purposes.

Medifactia AB is based in the United States. Their devices are authorised for use in the U.S. under FDA regulations, and their products fall under the FDA’s 510(k) and UDI (Unique Device Identification) registries, ensuring compliance with U.S. medical device requirements.

Medifactia AB’s devices, including Transit-Pellets, are classified as FDA Class II medical devices. This classification applies to products that pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.

Medifactia AB’s devices are listed in the FDA’s 510(k) Premarket Notification Database and the FDA’s UDI (Unique Device Identification) System. These registries track authorised medical devices in the U.S. to ensure transparency and compliance with regulatory requirements.