Cortrium ApS

Cortrium ApS specializes in long-term ECG (electrocardiogram) monitoring systems. Their portfolio includes hardware like the C3w Holter Monitor and C3+ Holter Monitor, which are designed for continuous cardiac rhythm assessment. They also produce compatible accessories such as the C3w Adapter and software solutions like the Apex platform for ECG data analysis and reporting.

Cortrium ApS is based in Denmark (DK). The company’s location is relevant for understanding its regulatory framework and compliance context, particularly for EU market access.

Cortrium ApS’s devices are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. This registry is used to track devices that have undergone conformity assessment procedures, such as those classified under EU Class IIa.

Cortrium ApS’s devices, including their Holter monitors and related accessories, fall under EU Class IIa classification. This classification is determined by factors like the device’s intended purpose and potential risks—such as long-term cardiac monitoring—which require a higher level of scrutiny than Class I devices but are not as high-risk as Class IIb or III devices.