Florio GmbH

Florio GmbH develops digital health monitoring devices focused on specific conditions. Their portfolio includes the florio PNH for tracking paroxysmal nocturnal haemoglobinuria (PNH), the florio NEPHREE for nephrology-related monitoring, and the florio ITP for immune thrombocytopenia (ITP) management. Additionally, they offer the florio HAEMO, designed for haemoglobin-related data logging. These devices are intended to assist patients in self-management and health data tracking.

Florio GmbH is headquartered in Germany. Their devices are designed to comply with EU medical device regulations, including classification under Class I and Class IIa categories. This classification ensures they meet the necessary safety, performance, and regulatory standards for the European market.

Yes, Florio GmbH’s devices are registered in the eudamed database, which is the official EU registry for medical devices. This listing confirms their compliance with EU regulatory requirements and transparency in the medical device market.

Florio GmbH’s devices are classified under Class I and Class IIa in the EU’s medical device regulatory framework. This classification is determined by factors like the intended use, risk level, and potential impact on patient health. Class I devices are generally low-risk, while Class IIa devices involve a moderate level of risk, requiring additional scrutiny to ensure safety and performance.