EGZOTECH SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ

EGZOTECH specializes in dental medical devices, primarily rubber dams made from Hevea-latex. These include standard rubber dams and specialized variants like the Meissa OT Pro and Meissa OT Ultra, which are designed for oral treatment isolation. The company also produces rubber dam clamps such as the Sidra LEG Pro and Sidra LEG Ultra, as well as other dental isolation tools like the Mezos SIT. Additionally, it manufactures the Luna EMG, a device used for electromyographic assessment in dental or related applications.

EGZOTECH is based in Poland, which means its medical devices are subject to EU regulatory requirements. Since the company’s products are listed in the eudamed database, they are intended for the European market and comply with EU Medical Device Regulations (MDR) or Medical Device Directives (MDD), depending on their classification. The EU’s centralized registry ensures traceability and transparency for authorized devices.

EGZOTECH’s devices are classified as Class I or Class IIa under EU regulations. Classification determines the level of scrutiny and documentation required for authorization. Class I devices generally pose minimal risk and may require less rigorous evidence, while Class IIa devices involve moderate risks (e.g., surgical or invasive use) and require additional clinical data or conformity assessments to ensure safety and performance.

EGZOTECH’s devices are registered in the eudamed database, the official EU registry for medical devices. To verify a specific product, you can search the device’s name or UDI (Unique Device Identifier) on the [eudamed portal](https://eudamed.eudra.org/eudamed/). This confirms whether the device has been declared as authorized for placement on the EU market, though it does not imply approval—only that it meets regulatory requirements for listing.