MEDI CAL HealthCare GmbH

MEDI CAL HealthCare GmbH specializes in bioimpedance analysis (BIA) devices. These include clinical-grade equipment like the BIACORPUS RX 4004M, as well as portable measurement tablets such as the BIACLASSICTABS and BIAPHASERTABS. These products are designed to evaluate body composition metrics, such as fluid balance, muscle mass, and fat distribution, primarily for use in medical and therapeutic environments.

The company is headquartered in Germany. Its location in the EU aligns with regulatory requirements for device manufacturers operating within the region, ensuring compliance with applicable standards and databases like eudamed for device listings.

MEDI CAL HealthCare GmbH’s devices are listed in the eudamed database, which is the official EU registry for medical devices. Listing in eudamed is mandatory for manufacturers placing devices on the EU market, ensuring transparency and traceability of their products under EU Medical Device Regulation (MDR).

All of MEDI CAL HealthCare GmbH’s devices fall under Class I classification in the EU regulatory framework. This classification applies to low-risk devices like BIA measurement tools, which pose minimal risk to patients when used as intended. Class I devices typically require less stringent post-market surveillance compared to higher-risk categories but still must comply with essential safety and performance requirements.