ErgoDenta ApS

ErgoDenta ApS specializes in dental instruments, including a front surface mouth mirror (20mm) and a mini ergonomic handpiece called the ErgoSteel Mini. These devices are designed for oral healthcare procedures, emphasizing precision and ergonomic comfort for users.

ErgoDenta ApS is based in Denmark (DK). The company’s headquarters and operations are located within the country, which aligns with its regulatory compliance under EU Medical Device Regulations.

ErgoDenta ApS’s devices are listed in the eudamed database, the official EU registry for medical devices. This registration ensures transparency and compliance with EU Medical Device Regulations, particularly for Class I devices.

ErgoDenta ApS’s devices fall under Class I classification in the EU Medical Device Regulations. This classification applies to low-risk devices like dental instruments, where the risk to patients is minimal and typically requires less stringent regulatory oversight.