Medical Devices Notice

Sale to professional customers only

The products offered in this shop are medical devices and dental materials for dental, dental-technical and professional use. They are sold exclusively to professional and business customers (B2B); we do not sell to consumers.

CE marking and conformity

We distribute only products bearing the CE marking for which an EU declaration of conformity issued by the manufacturer is available. Please always observe the manufacturer’s labelling, instructions for use and safety information. Product-related documents (e.g. safety data sheets, instructions for use) are available for download on the respective product page where available; we will be happy to send further documents on request.

Our obligations as a distributor (Art. 14 MDR)

As a distributor within the meaning of Regulation (EU) 2017/745 on medical devices (MDR), we fulfil the obligations under Art. 14 MDR: before making products available, we verify, among other things, the CE marking and conformity information, ensure proper storage and transport conditions, guarantee traceability and cooperate in corrective actions, recalls and official enquiries.

NEOMED DENTAL s. r. o. is registered in the Slovak Commercial Register with the business activity “large-scale distribution and distribution of medical devices” (veľkodistribúcia a distribúcia zdravotníckych pomôcok). The competent authority for medical devices in Slovakia is the State Institute for Drug Control (Štátny ústav pre kontrolu liečiv, ŠÚKL), Kvetná 11, 825 08 Bratislava.

Reporting of incidents

If an incident or product defect occurs in connection with a product purchased from us, please inform us immediately at office@dental-neomed.com – stating the product name, REF/LOT number and a brief description. We will forward the information to the manufacturer without delay and support the competent authorities within the scope of our cooperation obligations.

Version: September 2026