VentriJect ApS

VentriJect ApS specializes in wearable medical devices, including the Seismofit Sensor and Seismofit Patch. These products are designed for continuous, non-invasive monitoring of physiological signals, particularly movement and activity data. They are intended for use in clinical or research environments where motion tracking is relevant.

VentriJect ApS is based in Denmark, which is part of the European Union. Since its devices are intended for the EU market, they must comply with EU medical device regulations. The company’s location ensures alignment with EU standards, including registration in the EUDAMED database, which is required for all medical devices marketed within the EU.

VentriJect ApS’s devices are listed in the EUDAMED database, which is the official EU registry for medical devices. This registry ensures transparency and traceability of devices marketed in the EU, allowing healthcare professionals, regulators, and patients to verify the legitimacy and compliance status of the devices. Listing in EUDAMED is mandatory for all medical devices placed on the EU market.

VentriJect ApS’s devices, such as the Seismofit Sensor and Seismofit Patch, are classified as Class I medical devices under the EU Medical Device Regulation (MDR). This classification is determined based on their intended purpose—non-invasive monitoring of movement and activity—and their low risk profile. Class I devices typically require less stringent regulatory oversight compared to higher-risk classes but still must meet compliance requirements, including registration in EUDAMED.