CLB BV.

CLB BV manufactures the unicare2 MADS, a medical device specifically designed for patient monitoring and alert systems in healthcare environments. This device is intended to track patient vital signs in real-time and automate alerts for critical conditions, helping ensure timely medical responses. The device’s purpose aligns with improving patient safety and operational efficiency in clinical settings.

CLB BV is based in the Netherlands (NL), where it operates as a manufacturer of medical devices. The company’s headquarters and primary operations are located within this country, though its products may be used globally depending on regulatory authorisations and market access.

CLB BV’s devices, including the unicare2 MADS, are listed in the eudamed database, which is the European Union’s central registry for medical devices. This registry is used to track devices authorised under EU regulations, ensuring transparency and compliance with regulatory requirements.

The unicare2 MADS, manufactured by CLB BV, falls under EU Class IIb medical device classification. This classification is determined based on the device’s intended purpose, risk level, and potential impact on patient safety. Class IIb devices require stricter regulatory scrutiny than lower-risk classes but are not considered the highest risk (Class III).