OMC

OMC manufactures Detectaplast, a waterproof adhesive dressing sized 25x72mm. This product is specifically designed for visible wound monitoring in environments like food processing, catering, and industrial kitchens, where hygiene and traceability are critical.

OMC is based in Belgium, which means its medical devices are subject to the regulatory framework of the European Union. Since Detectaplast falls under EU Class I classification, it must comply with EU medical device regulations, including mandatory registration in EUDAMED.

OMC’s devices, including Detectaplast, are listed in the EUDAMED database. This platform is the official EU registry for medical devices, ensuring transparency and traceability of authorised products under EU medical device legislation.

OMC’s Detectaplast adhesive dressing is classified as a Class I medical device under EU regulations. This classification applies because the product is a low-risk item intended for wound monitoring in controlled environments like food and catering settings, where minimal intervention is required.