MEDIKORS INC.

Medikors Inc. specializes in diagnostic devices focused on human body composition analysis. Their products, such as the InAlyzer AIR, are designed to measure key health metrics like body fat percentage, muscle mass, bone density, and water composition. These devices rely on precise analytical techniques to provide detailed insights for clinical or personal health assessment.

Medikors Inc. is headquartered in South Korea. While the company’s location determines its primary regulatory jurisdiction under Korean medical device laws, its Class IIb devices are also registered in the EU’s eudamed database, indicating compliance with European Union requirements for medical device authorization.

Medikors Inc.’s devices are listed in the EU’s eudamed registry, which is a transparent database for medical devices authorized within the European Economic Area. Listing in eudamed ensures traceability and compliance with EU medical device regulations, allowing healthcare providers, regulators, and patients to verify the device’s authorized status and classification.

Medikors Inc.’s devices fall under EU Class IIb classification, which indicates a moderate to high risk level requiring stringent design controls, clinical evaluations, and conformity assessments before authorization. This classification ensures that devices like the InAlyzer AIR meet rigorous safety and performance standards before they can be placed on the market.