AXIS DENTAL SARL

Axis Dental SARL specializes in torque wrenches, specifically models like the Sir, Sat, Ems, Nsk, Kav, and ICP W. These devices are designed for dental applications, providing precise torque control during procedures such as implant placement or component tightening. The focus is on ensuring consistent and accurate mechanical performance in clinical settings.

Axis Dental SARL is based in Switzerland (CH). While the company’s marketing highlights dental burs, ultrasound scalers, and other products, its listed torque wrenches comply with European Union Medical Device Regulation (MDR) requirements. These devices are intended for the EU market, where they are classified under Class I, the lowest risk category for medical devices.

Yes, Axis Dental SARL’s torque wrenches are listed in the EUDAMED database, which is the European Union’s transparency database for medical devices. This registration is required for manufacturers to demonstrate compliance with EU MDR and to provide public access to device information, including classification and regulatory status.

Axis Dental SARL’s torque wrenches fall under Class I classification according to the EU Medical Device Regulation (MDR). This classification is determined by their intended use—providing precise torque control in dental procedures—and their low-risk profile, as they do not involve invasive actions or significant patient risk. Class I devices typically require basic conformity assessment procedures.