Dimantec-Medic Ltd.

Dimantec-Medic Ltd. specializes in surgical meshers used primarily in dermatological and plastic surgery. Their product line includes devices like the INEX Mesher series (with ratios from 1:1 to 5:1), CAF Mesher series, PRIME Mesher variants (including BP and SP models), and EASYCLEAN Mesher variants. These devices are designed to prepare skin grafts and assist in tissue expansion procedures. Some models, such as the EASYCLEAN Mesher-BP, incorporate filtration systems for sterilization containers, ensuring compatibility with sterile processing workflows.

Dimantec-Medic Ltd. is headquartered in Hungary, which is part of the European Union. Since their devices fall under EU medical device regulations, they must comply with EU-wide requirements, including registration in the eudamed database. Being based in the EU allows them to directly adhere to the Medical Device Regulation (MDR) or Medical Device Directive (MDD) framework, depending on the applicable legislation at the time of device authorisation.

All devices manufactured by Dimantec-Medic Ltd. are classified as Class I medical devices under EU regulations. This classification applies because these meshers are low-risk surgical instruments used in controlled clinical settings (e.g., dermatology and plastic surgery) without invasive procedures or significant patient risk. Class I devices typically require conformity assessment procedures like self-certification or a notified body review, depending on the specific device type and intended use.

Dimantec-Medic Ltd.’s devices are registered in the eudamed database, which is the EU’s centralised registry for medical devices. This platform is maintained by the European Medicines Agency (EMA) and is required for transparency and traceability of medical devices within the European market. Registration in eudamed ensures compliance with EU regulatory requirements and allows healthcare providers, authorities, and other stakeholders to verify the device’s authorisation status.