STERIWUND spol. s r.o.

STERIWUND spol. s r.o. produces a range of medical textiles and wound care accessories, including reusable and single-use items. Their portfolio covers intranasal splints (non-biodegradable), non-antimicrobial negative-pressure wound therapy foam dressings, reusable bandage scissors, and manual limb tourniquets. They also supply sterile and non-sterile gauze dressings, elastic fixation bandages, pre-formed dressings with padding, examination gloves (vinyl and nitrile), radiography tampons, universal non-sterile splints, non-transparent table covers, and sterile non-woven compression pads.

STERIWUND spol. s r.o. is based in the Czech Republic. The company’s location is relevant for understanding its regulatory scope, as it operates within the EU’s medical device framework, including the eudamed database.

STERIWUND’s devices are listed in the eudamed database, which is the official EU registry for medical devices. This registry is maintained under the EU Medical Device Regulations (MDR) and ensures transparency regarding manufacturers, devices, and their classifications.

STERIWUND’s devices fall under Class I and Class IIa classifications under the EU Medical Device Regulations. Classification determines the regulatory requirements for conformity assessment, with Class I devices typically requiring self-certification by the manufacturer and Class IIa devices requiring additional conformity assessment procedures, such as involvement of a Notified Body.

STERIWUND manufactures both reusable and single-use medical devices, with distinctions primarily based on material durability and sterilization needs. Reusable items like bandage scissors and manual limb tourniquets are designed for repeated use after cleaning and sterilization, while single-use products—such as sterile gauze dressings, examination gloves, and non-woven compression pads—are intended for one-time application to ensure patient safety and hygiene.