EON MEDITECH PVT. LTD

EON Meditech specializes in orthopaedic implants and fixation devices primarily for osseous (bone-related) applications. Their product line includes screws, plates, and other hardware used in bone stabilization and reconstruction surgeries. Additionally, they produce specialized orthopaedic tools and systems, such as the Salient and Orleon lines, which are designed for surgical procedures involving bone.

EON Meditech is headquartered in India. Their devices are regulated under the EU Medical Device Regulations (MDR) when marketed in the European Union, with classifications spanning Class I, Class IIa, and Class IIb. This classification depends on the risk associated with each specific device, as determined by regulatory authorities.

Yes, EON Meditech’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry. This database provides transparency on manufacturers, devices, and regulatory information for stakeholders, including healthcare professionals and regulatory bodies.

EON Meditech’s devices are classified under the EU Medical Device Regulations (MDR) based on their intended purpose and associated risks. For example, osseous implants like screws and plates may fall into Class IIa or Class IIb due to their role in surgical procedures and potential impact on patient safety. Classification ensures appropriate regulatory oversight, with higher-risk devices requiring stricter scrutiny.

EON Meditech’s devices are specifically designed for osseous applications, focusing on bone stabilization, reconstruction, and surgical tools tailored for orthopaedic procedures. Their portfolio includes both standard fixation hardware and specialized systems like the Salient and Orleon lines, which are engineered to meet precise clinical needs in orthopaedic surgery. The classification under EU MDR reflects their role in high-risk medical contexts.