IDROFIL S.R.L

Idrofil S.r.l. specializes in single-use medical cotton products. These include pre-cut and bulk hydrofilous cotton in various weights (such as 50g, 80g, 100g, and 1000g) designed for medical and pharmacy applications. The company also produces disposable bed rail protectors and mattress savers, all intended for one-time use in healthcare settings.

Idrofil S.r.l. is based in Italy, which means its products are manufactured under Italian regulatory oversight. Since the company’s devices fall under the EU Medical Device Regulation (MDR), they are subject to EU-wide compliance requirements, ensuring they meet safety, performance, and quality standards for use within the European market.

Idrofil S.r.l.’s devices are listed in the EUDAMED database, which is the official European Union database for medical devices. This registry allows healthcare professionals, regulators, and authorities to verify the manufacturer’s details, device classifications, and compliance information. Listing in EUDAMED is a requirement under the MDR to ensure transparency and traceability of medical devices in the EU market.

Idrofil S.r.l.’s products are classified as Class I medical devices under the EU Medical Device Regulation (MDR). This classification applies to low-risk devices like single-use cotton products and disposable bed protectors, which generally pose minimal risk to patients and users. Class I devices still require compliance with essential safety and performance requirements but typically undergo less stringent post-market surveillance than higher-risk classes.