Storz & Bickel GmbH

Storz & Bickel GmbH specializes in dental and oral surgery instruments, including systems like the MIGHTY+ MEDIC and VOLCANO MEDIC 2. These devices are engineered for precision cutting and bone preparation, primarily used in dental implantology and restorative treatments. The company’s portfolio also includes accessories tailored for surgical applications within oral healthcare.

Storz & Bickel GmbH is headquartered in Germany, which places its operations under the jurisdiction of EU medical device regulations. Since the company’s devices are designed for the European market, they must comply with EU requirements, including classification under the Medical Device Regulation (MDR) or Medical Device Directive (MDD). This ensures alignment with EU standards for safety, performance, and traceability.

Storz & Bickel GmbH’s devices are listed in the eudamed database, the official EU registry for medical devices. This registration is critical because it provides transparency to healthcare professionals, regulators, and authorities about the devices’ compliance status, manufacturer details, and classification. It also facilitates traceability and market surveillance under EU medical device laws.

Storz & Bickel GmbH’s devices fall under Class IIa classification in the EU. This classification is determined based on factors like the device’s intended purpose, potential risks, and patient contact duration. Class IIa devices are considered to have a moderate risk and require additional scrutiny, such as clinical evaluations and conformity assessments, to ensure their safety and performance before market placement.