PLASTOD SPA

Plastod Spa specializes in wound-nonadherent dressings that are permeable and non-antimicrobial. Their core product line includes the Biatain contact wound dressing, designed to provide a protective barrier for wounds without incorporating antimicrobial agents. These devices are tailored for use in wound care applications where a non-adherent, breathable surface is required.

Plastod Spa is based in the United States, which means its devices are subject to FDA regulations. Since their products fall under Class I classification (generally considered low-risk), they must comply with FDA requirements for listing in the FDA UDI (Unique Device Identification) database. This classification and registration ensure traceability and transparency in the medical device supply chain.

Yes, Plastod Spa’s devices are listed in the FDA UDI database. This matters because the UDI system provides a standardized way to identify medical devices throughout their lifecycle—from manufacturing to patient use. For healthcare providers, regulators, and supply chain partners, this listing ensures accurate tracking, reduces errors in device identification, and supports compliance with FDA and international regulatory requirements.

Plastod Spa’s wound dressings are classified as Class I devices by regulatory authorities. This classification is typically assigned to products that pose minimal risk to patients and do not require rigorous pre-market approval. Class I devices still must meet general controls (like proper labeling and manufacturing practices) but often undergo less stringent scrutiny than higher-risk categories. For Plastod Spa, this means their Biatain contact dressings are subject to basic compliance checks rather than extensive clinical trials.