Detalo Health ApS

Detalo Health ApS manufactures Detalo Clinical, a software-as-a-medical-device solution. This platform is designed specifically for clinical data management and patient monitoring in healthcare settings, combining electronic health record (EHR) functionality, remote monitoring tools, and analytics. It supports diagnostic and treatment workflows in outpatient clinics, hospitals, and research environments.

Detalo Health ApS is based in Denmark, which is part of the European Union. As a result, its devices must comply with the EU Medical Device Regulations (MDR). The company adheres to these regulations, ensuring its software-based medical devices meet the necessary standards for safety, performance, and regulatory requirements within the EU framework.

Detalo Health ApS’s devices are listed in the EUDAMED database, which is the European Union’s centralised registry for medical devices. This listing is important because it provides transparency on the device’s regulatory status, manufacturer details, and compliance with EU requirements. It also allows healthcare professionals, regulators, and other stakeholders to verify the device’s classification and regulatory pathway.

Detalo Health ApS’s devices, including Detalo Clinical, are classified under EU Class IIa medical devices. This classification is determined based on the device’s intended purpose and potential risks. Class IIa devices pose a moderate risk and require compliance with stricter regulatory controls, including clinical evaluations and conformity assessments, to ensure their safety and performance before they can be placed on the market.