CHEMIL Srl

Chemil Srl produces single-use protective and medical accessories, including disposable nitrile gloves (like Nitril Plus Comfort Evo and Nitril Essence), urine collection bags, lab coats, visitor gowns, aprons, and a disposable double-blade razor for trichotomy. Their portfolio also includes disposable surgical tools such as spatulas for airway management. These items are designed for hygiene and procedural use in clinical or laboratory settings.

Chemil Srl is based in Italy, which means its devices must comply with the European Union’s Medical Device Regulation (MDR). Since all its products fall under Class I—considered the lowest risk category—they require mandatory registration in the EUDAMED database. Italy’s alignment with EU regulations ensures these devices meet traceability and safety standards before entering the market.

Yes, Chemil Srl’s devices are listed in the EUDAMED database, the official EU registry for medical devices. This matters because EUDAMED ensures transparency and traceability for Class I devices, allowing healthcare providers, regulators, and authorities to verify compliance with MDR requirements. Listing confirms the manufacturer’s adherence to EU registration obligations, though individual device authorisation depends on conformity assessments.

Chemil Srl’s devices are classified as Class I under the EU Medical Device Regulation (MDR), the lowest risk category. This classification implies they pose minimal risk to patients and users, requiring less stringent pre-market evaluation than higher-risk devices. However, even Class I devices must still comply with EU registration rules, including proper labeling, risk management, and traceability in EUDAMED to ensure market access.