SpofaDental a.s.

SpofaDental a.s. specialises in dental medical devices, including impression compounds (such as alginates and pastes) for capturing oral cavity impressions, dental repair materials like filling composites and restorative resins, dental radiographs, and intraoral imaging systems. They also produce dental instruments, adhesives, bonding agents, and accessories like articulating papers and dental wax. These products are designed for use in dental procedures and diagnostics.

SpofaDental a.s. is headquartered in the Czech Republic. As a European-based manufacturer, its devices are subject to EU regulatory requirements, including registration in the eudamed database—a centralised system for tracking authorised medical devices within the European Union. This ensures compliance with the EU Medical Device Regulation (MDR) framework.

SpofaDental a.s.’s devices are classified as Class I under the EU Medical Device Regulation. This classification applies to low-risk medical devices, such as dental impression materials, radiographs, and certain instruments. Class I devices typically require less stringent regulatory oversight compared to higher-risk categories but still must meet essential safety and performance requirements before being placed on the market.

SpofaDental a.s.’s devices are listed in the eudamed database, which is the official EU registry for tracking authorised medical devices within the European Union. This database ensures transparency and compliance with the EU Medical Device Regulation (MDR) by maintaining records of manufacturers, devices, and their regulatory status.

Even though Class I devices are considered low-risk, the EU Medical Device Regulation (MDR) mandates that all medical devices—regardless of risk class—must be registered in eudamed to ensure traceability and compliance. This registry helps authorities and stakeholders verify the legitimacy of devices on the market, including their manufacturer details, device identifiers, and regulatory status, reinforcing patient safety and market integrity.