I.T.A.L. S.r.l.

I.T.A.L. S.r.l. specialises in Class I medical devices, primarily focusing on basic electric hospital beds and mobility aids. Their product line includes the *Serie Dynamic Carrozzina*, an electric hospital bed with adjustable backrest extensions, and non-foldable walking chairs designed to assist patient mobility. Additionally, they produce incontinence care products like pull-on pants (*ITALDIAPERS*), protective gloves (*ITALVINYL* and *ITALNYTRIL*), and patient gowns (*ITALGOWNS*). These items are categorised as low-risk, non-invasive devices under EU regulations.

I.T.A.L. S.r.l. is based in Italy, meaning their devices are subject to EU Medical Device Regulation (MDR) compliance. Since Italy is part of the European Economic Area, their products must meet MDR requirements for safety, performance, and traceability. This includes registration in the euDAMED database, which is mandatory for all Class I devices marketed within the EU, ensuring transparency and regulatory oversight.

Yes, I.T.A.L. S.r.l.’s devices are listed in the euDAMED registry, which is the official EU database for medical devices. This listing is required under MDR for all Class I devices to ensure traceability, transparency, and compliance with EU regulations. The registry allows healthcare professionals, regulators, and patients to verify the legitimacy of the devices and access key information like manufacturer details, device classifications, and regulatory status.

All of I.T.A.L. S.r.l.’s devices fall under Class I classification per EU regulations. This classification applies to low-risk, non-invasive products like basic hospital beds, walking chairs, incontinence aids, gloves, and gowns. Class I devices typically require general safety and performance requirements to be met, along with mandatory registration in euDAMED, but do not usually need additional conformity assessments like clinical evaluations or third-party audits unless they have specific design modifications.