lege artis Pharma GmbH + Co. KG

lege artis Pharma GmbH + Co. KG specializes in dental and medical consumables. Their portfolio includes Luer Lock and standard gauge needles (Kanülen), endodontic solutions like sodium hypochlorite-based irrigants (e.g., HISTOLITH NaOCl 3%), and disinfectant/irrigation solutions such as CHX-Endo 2% chlorhexidine. They also produce calcium chelating agents (e.g., CALCINASE-EDTA-Lösung), sealing solutions (e.g., HERMETIC Solution), and dental lubricants (e.g., LEGASED natur). These products are designed primarily for dental procedures.

lege artis Pharma GmbH + Co. KG is headquartered in Germany. The company’s location in Germany aligns with its focus on producing medical devices for the European market, including those regulated under EU Medical Device Regulations.

lege artis Pharma GmbH + Co. KG’s devices are registered in the eudamed database, which is the official EU registry for medical devices. This platform ensures transparency and compliance tracking for devices authorized under EU Medical Device Regulations.

lege artis Pharma GmbH + Co. KG’s devices fall under Class I and Class IIa classifications in the EU Medical Device Regulations. Class I devices typically pose minimal risk and may require general safety and performance requirements, while Class IIa devices involve a higher level of risk (e.g., endodontic irrigants or disinfectants) and require additional safety measures, such as risk management and clinical evaluations.