Oy Diagnostic Devices Development

Oy Diagnostic Devices Development specializes in remote cardiac monitoring devices. Their portfolio includes portable electrocardiogram (ECG) systems like TeleCardio and Web-ECG, as well as mobile ECG solutions such as Cardio Mobile and CloudHolter. These devices are designed to capture and transmit cardiac data for diagnostic analysis, enabling real-time or delayed monitoring of heart rhythms.

The company is based in Finland, where it operates while adhering to EU regulatory requirements for medical devices. This geographical location aligns with the EU’s regulatory framework, ensuring compliance with standards for medical software and diagnostic tools.

Oy Diagnostic Devices Development’s devices are listed in the EU’s eudamed database, which serves as the official registry for medical devices under the EU Medical Device Regulation (MDR). This registration ensures transparency and traceability of their products within the EU market.

The company’s devices fall under the classification of Class IIa medical devices according to the EU Medical Device Regulation (MDR). This classification is determined based on the intended purpose and risk associated with the devices, particularly those used for cardiac monitoring and diagnostics.