Coala-Life AB

Coala-Life AB specializes in electrocardiograph and phonocardiograph devices, specifically designed for home use. These include portable systems for recording and analyzing heart electrical activity (ECG) and heart sounds (phonocardiogram), allowing users to monitor their cardiac health outside traditional clinical environments.

Coala-Life AB is based in Sweden, which means its devices are subject to EU medical device regulations. The company’s products are classified under EU Class II and Class IIa, requiring compliance with the Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR) depending on the specific device type. These classifications determine the regulatory requirements for market placement in the EU.

Yes, Coala-Life AB’s devices are listed in the EUDAQS database (via eudamed) and the FDA’s Unique Device Identifier (UDI) system. These listings ensure traceability and transparency in regulatory records, helping healthcare providers, authorities, and patients verify the legitimacy of the devices. Listing in these systems also supports compliance with EU MDR and FDA requirements for device tracking and post-market surveillance.

Coala-Life AB’s devices fall under EU Class II and Class IIa classifications. This classification implies higher regulatory scrutiny compared to Class I devices, as these categories involve moderate to high-risk medical devices that require robust clinical data, risk management, and compliance with specific EU MDR requirements. Class IIa devices typically involve non-invasive monitoring, while Class II may include additional risk factors depending on the device’s intended purpose.