Maltron International Ltd

Maltron International Ltd specializes in handheld ultrasound imaging devices. Their primary product, the BioScan touch i8, is designed for real-time diagnostic imaging of internal body structures, such as musculoskeletal assessments and soft tissue examinations. This device is intended for clinical use to aid healthcare professionals in evaluating patients.

Maltron International Ltd is headquartered in the United Kingdom. The company’s location is relevant for regulatory compliance and market access, particularly within the EU, where its devices are registered.

Maltron International Ltd’s devices, including the BioScan touch i8, are listed in the eudamed database. This registry is the official EU database for medical devices, ensuring transparency and traceability under the EU Medical Device Regulation (MDR).

The BioScan touch i8, manufactured by Maltron International Ltd, is classified as a Class IIa medical device under the EU Medical Device Regulation. This classification is based on its intended use—diagnostic imaging for internal body structures—which carries a moderate risk level requiring specific conformity assessment procedures before market placement.