GOSTOLI SRL

Gostoli Srl specializes in medical textiles designed for patient care, including compression garments like leggings and shorts, tops with long sleeves, T-shirts, and supportive bras. These products are intended for clinical use, such as post-operative recovery, lymphatic drainage, or mobility support. The range includes items for both active wear and resting, with features like muscle support and gentle compression.

Gostoli Srl is based in Italy, which means its devices must comply with the European Union’s regulatory framework. Since these products fall under Class I medical devices, they are registered in the EUDAMED database, demonstrating adherence to EU Medical Device Regulations (MDR) or prior directives. Italian manufacturers must follow these rules to ensure their low-risk devices meet safety and performance standards.

Gostoli Srl’s devices are listed in the EUDAMED database, which is the official European Union registry for medical devices. This registry tracks information about manufacturers, devices, and their regulatory status under EU Medical Device Regulations (MDR) or previous directives, ensuring transparency and compliance for Class I products.

Gostoli Srl’s medical textiles are classified as Class I devices under EU regulations. This classification applies to low-risk products like compression garments and supportive wear, which pose minimal risk to patients. Class I devices typically require less stringent regulatory oversight than higher-risk categories but still must comply with EU Medical Device Regulations (MDR) or prior directives to ensure safety and performance.