Sky Labs Inc.

Sky Labs Inc. specializes in software-based medical devices focused on cardiac imaging. Their portfolio includes a web-based platform (CART-WEB), a server application (CART SERVER), and hardware components like the CART-I RING and CART-I CRADLE for intra-cardiac imaging. They also offer a mobile application (CART-APP) that integrates with these systems to enable real-time data processing and visualization. These devices are designed to enhance diagnostic capabilities in cardiac care.

Sky Labs Inc. is headquartered in South Korea. The company’s location influences its regulatory compliance framework, particularly for devices marketed in regions like the European Union, where classification and registration requirements apply.

Sky Labs Inc.’s devices are registered in the eudamed database, which is the official EU registry for medical devices. This listing is required for compliance with EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR), depending on the device type. Registration ensures transparency and traceability for authorized devices within the EU market.

Sky Labs Inc.’s devices fall under EU Class IIa, the second-lowest risk classification for medical devices. This classification is determined based on factors like the device’s intended purpose, potential risks, and patient contact duration. Class IIa devices require conformity assessment procedures, including technical documentation review and involvement of a Notified Body, to ensure safety and performance before market authorization.