Nuovo Therapy s.r.o.

Nuovo Therapy s.r.o. specializes in photobiomodulation devices, which use light therapy to promote tissue regeneration, pain relief, and wound healing. Their portfolio includes devices like the Pulse3000 Dual7, Pulse1500 Dual7, Nuovo LED Bed, Pulse6000 Dual7, and Pulse300 Dual7. These devices are designed for applications such as musculoskeletal pain, post-operative recovery, joint and back pain, and soft tissue injuries.

Nuovo Therapy s.r.o. is headquartered in Slovakia. The company’s location in Slovakia places it within the European Union, which influences its regulatory compliance and device classification processes.

Yes, Nuovo Therapy’s devices are registered in the EUDAMED database, which is the European Union’s medical device registry. This database tracks devices that have undergone the necessary conformity assessment procedures to comply with EU medical device regulations.

Nuovo Therapy’s devices fall under EU Class I classification. This classification is typically assigned to low-risk medical devices, such as those that do not directly interact with the body in a way that poses significant risk (e.g., non-invasive light therapy devices). Class I devices still require compliance with EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR) but generally involve less stringent post-market surveillance compared to higher-risk classes.