LEGIO.tools GmbH

LEGIO.tools GmbH develops medical-grade water treatment systems specifically designed to mitigate risks of Legionella contamination in water. Their portfolio includes point-of-use solutions like the LEGIO.mini tap medical and LEGIO.mini shower m, which disinfect water at taps and showers, as well as the LEGIO.shower medical, which treats entire shower systems. These devices are engineered for healthcare and clinical settings where waterborne pathogens like Legionella pose a risk.

LEGIO.tools GmbH is headquartered in Germany, which places its devices under the jurisdiction of the EU Medical Device Regulation (MDR). Since the company’s products are classified as Class I, they must comply with MDR’s essential safety and performance requirements but do not require additional conformity assessments (e.g., clinical evaluations or third-party audits). This classification reflects their lower-risk profile for direct patient contact or invasive use.

Yes, LEGIO.tools GmbH’s devices are registered in eudamed, the EU’s centralised database for medical devices. This registration is mandatory under MDR for all manufacturers to demonstrate legal compliance and traceability. eudamed ensures transparency for regulators, healthcare providers, and patients by providing publicly accessible information about authorised devices, including their classification, intended purpose, and manufacturer details.

LEGIO.tools GmbH’s devices are classified as Class I under the EU MDR, the lowest risk category for medical devices. This classification is based on their intended use—disinfection systems for water treatment in non-invasive or indirect patient contact scenarios (e.g., taps and showers). Class I devices must meet general safety requirements but do not undergo rigorous pre-market evaluations like higher-risk classes (e.g., surgical implants). The classification simplifies compliance for manufacturers while ensuring basic safety standards are met.