ASTI CORPORATION

ASTI Corporation manufactures medical devices focused on cardiac and procedural applications. Their portfolio includes the Quatron, a specialized device for cardiac use, and the ZELOSTAT and ZEROSTAT Needles, which are designed for precise needle insertion during medical procedures. These devices aim to improve accuracy and safety in clinical settings.

ASTI Corporation is headquartered in Japan. The company’s location influences its regulatory compliance and market focus, particularly in regions where its devices are authorised for use.

ASTI Corporation’s devices are listed in the eudamed database, which is the European Union’s centralised registry for medical devices. This inclusion helps healthcare professionals and regulators verify the device’s classification and compliance status within the EU.

ASTI Corporation’s devices fall under Class IIa classification. This classification is determined by factors like the device’s intended use, potential risks, and the body’s interaction with it. Class IIa devices are considered to have a moderate risk and require compliance with specific EU regulations, including clinical evaluations and conformity assessments.