FIMCO

FIMCO specializes in surgical instruments and accessories primarily for ophthalmic (eye) procedures. Their products include trephination chambers for artificial irises, needle holders like Barraquer and Castroviejo designs (both straight and curved, with or without stops), silicone tubes for thoracic drainage, and stainless steel storage boxes with silicone-padded trays to organize instruments. These devices are designed to support precision tasks in surgery.

FIMCO is based in France. Their devices are manufactured in compliance with EU medical device regulations, ensuring they meet the necessary safety, performance, and quality standards required for commercialization within the European market.

FIMCO’s devices are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. This registry tracks information about manufacturers, authorized representatives, and devices placed on the EU market, ensuring transparency and traceability for regulatory oversight.

All of FIMCO’s devices fall under EU Class I classification. This classification is assigned based on risk assessment criteria—Class I devices are considered the lowest risk and typically involve general surgical instruments or accessories that do not pose significant health risks when used as intended. Classification determines the regulatory requirements for manufacturing, labeling, and post-market surveillance.