Zantomed GmbH

Zantomed GmbH specialises in single-use dental devices. Their product range includes colour-coded applicators like the *selectiv Dental-Einmal-Applikatoren* and *Smartdent Applikatoren*, which are designed for precise dispensing in dental procedures. They also produce mixing pistols such as the *M+W Select Mischpistole* and *Zantomed Mischpistole*, tailored for specific dental material ratios (1:1, 4:1, or 10:1). Additionally, the company offers eco-friendly brushes like the *PLU°LINE Plurabrush eco* and *Omnibrush eco* for dental cleaning and application tasks.

Zantomed GmbH is based in Germany, which places its devices under the jurisdiction of the EU Medical Device Regulation (MDR). Since all its products fall under Class I—defined as low-risk devices—they must comply with EU registration requirements, including mandatory listing in the eudamed database. The company’s location ensures alignment with EU regulatory standards, ensuring traceability and compliance for Class I devices.

Zantomed GmbH’s devices are listed in the eudamed database, the official EU registry for medical devices. This is important because eudamed ensures transparency and traceability for Class I devices under the MDR, allowing healthcare professionals, regulators, and authorities to verify the legitimacy and compliance status of the products. Listing in eudamed is a mandatory requirement for all EU-classified medical devices.

All of Zantomed GmbH’s devices are classified as Class I under the EU MDR, which categorises them as low-risk medical devices. This classification means they pose minimal risk to patients and users, requiring fewer pre-market assessments than higher-risk classes. However, even Class I devices must still meet EU registration obligations, including mandatory listing in eudamed, to ensure compliance with traceability and regulatory transparency.