NUXEN SRL

NUXEN SRL specializes in removable dental prostheses components. Their portfolio includes bulk acrylic resin materials (like BULKFLEX variants), pre-made denture teeth (such as MELTYX and FLUENCESR series), and customizable denture base resins (e.g., ACETALAC and M10 XR). These products are designed for dental laboratories to create partial or full removable dentures, with variations in size, shape, and material properties like transparency or color. Their offerings also cover specialized acrylic resin blends for denture bases and elastomeric materials for flexible denture liners.

NUXEN SRL is headquartered in Argentina, where it operates under local and international standards for removable dental prostheses. While the company’s location influences its regulatory compliance framework (e.g., adherence to Argentinean and regional standards), its devices are registered in the EU’s euDAMED database as Class I medical devices. This classification means they meet basic safety and performance requirements without needing pre-market authorization beyond registration.

Yes, all of NUXEN SRL’s devices are listed in the euDAMED database, which is the European Union’s official registry for medical devices. This inclusion confirms their compliance with EU requirements for Class I devices, which do not require pre-market authorization beyond mandatory registration. The registry serves as a transparent public resource for tracking authorized devices within the EU market.

NUXEN SRL’s devices are classified as Class I under EU medical device regulations. This classification applies to low-risk products like removable dental prostheses components, which pose minimal risk to patients. Class I devices are subject to general safety and performance requirements but do not require pre-market authorization procedures beyond registration in databases like euDAMED. The classification ensures they meet basic regulatory standards without additional scrutiny.