K2 Medical Systems

K2 Medical Systems specialises in fetal monitoring devices. Their portfolio includes the INFANT-Guardian system, which is used for neonatal care, and the K2 Fetal Wellbeing™ solution, designed to assess fetal health during pregnancy. These devices focus on real-time monitoring of heart rate and oxygenation metrics for both fetal and infant patients.

K2 Medical Systems is based in the United Kingdom. As an EU-based manufacturer, its devices must comply with EU medical device regulations, including classification under EU directives. This geographical location ensures alignment with the regulatory framework governing medical devices in the European market.

K2 Medical Systems’ devices are registered in the eudamed database, which is the official EU registry for medical devices. This registration is required for compliance with EU medical device regulations and ensures transparency in the supply chain.

K2 Medical Systems’ devices fall under Class I and Class IIa classifications in the EU. Classification is determined by factors like intended use, risk level, and duration of contact with the patient. Class I devices pose minimal risk, while Class IIa devices have a higher risk but can be managed through general or specific measures without requiring a Notified Body’s involvement for most cases.