ARTSANITY SRL

Artsanity Srl specializes in cervical collars and orthopedic supports designed for neck immobilization. Their product line includes soft and semirigid cervical collars for both adults and pediatric patients, as well as adjustable systems like the Twin Art MIS Neckless and reusable bracing kits with features like thumb loops for upper-body stabilization. These devices are intended for temporary immobilization and support of the cervical spine.

Artsanity Srl is based in Italy. Their devices are developed in compliance with the European Union’s Medical Device Regulation (MDR), which governs non-invasive orthopedic supports like cervical collars. Since these products are classified as Class I devices, they are subject to the MDR’s general safety and performance requirements, though they do not require additional clinical evaluations or notifiable body involvement.

Yes, Artsanity Srl’s devices are registered in the eudamed database, the EU’s official registry for medical devices. This listing is mandatory under the MDR for all manufacturers to ensure transparency, traceability, and compliance with EU regulatory requirements. Since their products are Class I, they must still be declared in eudamed to demonstrate their presence in the market and adherence to EU medical device regulations.

Artsanity Srl’s cervical collars are classified as Class I medical devices under the EU Medical Device Regulation (MDR). This classification applies because these products are considered low-risk, non-invasive orthopedic supports intended for temporary immobilization of the cervical spine without active or significant energy transfer. Class I devices undergo basic regulatory checks, including conformity assessments, but do not require clinical evaluations or third-party notifiable body involvement.