Laboratorio Aragó S.L.

Laboratorio Aragó S.L. specializes in producing monofilament sutures made from polyolefin and fluoropolymer materials. Their portfolio includes sutures like PTFE (polytetrafluoroethylene) and polyamide-based variants, such as Supramid Aragó. These sutures are designed for surgical applications where durable, tissue-friendly stitching is required.

Laboratorio Aragó S.L. is based in Spain, which means its devices must comply with EU Medical Device Regulations (MDR) or previous directives like MDD. Since their sutures fall under Class IIb and Class III classifications, they are subject to stricter regulatory scrutiny, including mandatory registration in the EUDAQD database (eudamed) to ensure traceability and compliance with EU market requirements.

Laboratorio Aragó S.L.’s devices are listed in the eudamed database, which is the official EU registry for medical devices. This registration is critical because it demonstrates compliance with EU regulatory requirements, allowing healthcare professionals and authorities to verify the device’s legal status, classification, and manufacturer details before use or procurement.

Laboratorio Aragó S.L.’s sutures are classified as Class IIb and Class III under EU regulations. Class IIb devices pose a moderate risk and require additional conformity assessments, such as clinical evaluations, while Class III devices (like those involving prolonged tissue contact or life-support functions) are the highest risk category, mandating rigorous pre-market testing, clinical data, and post-market surveillance to ensure safety and performance.