Careva System AB

Careva System AB produces a range of adjustable orthopedic belts and buckles primarily for mobility and medical support. Their product line includes hip (pelvic) belts in sizes S and M, spinal belts, shoulder belts, chest belts, and both metallic and plastic buckles. They also offer specialized devices like the Crossit and Crossit 2.0, which appear to target spinal or postural stabilization, as well as combination belts designed for multi-point stabilization. These devices are intended to assist individuals in maintaining mobility, participating in activities, and ensuring safe transport.

Careva System AB is based in Sweden. Since their devices fall under EU Medical Device Regulation (MDR) Class I, they must comply with EU regulatory standards for medical devices, including registration in the EUDAMED database. This classification means their products are subject to essential safety and performance requirements, though they do not require additional pre-market approval beyond conformity assessment procedures.

Yes, Careva System AB’s devices are registered in the EUDAMED database, which is the official European Union database for medical devices. This registry ensures transparency and traceability of devices placed on the market under EU regulations, including compliance with MDR requirements for Class I devices.

Careva System AB’s devices are classified as Class I under the EU Medical Device Regulation (MDR). This classification is typically assigned to low-risk devices that do not require invasive procedures or sustained use within the body. Class I devices must still meet essential safety and performance requirements, but they often undergo simplified conformity assessment procedures compared to higher-risk classes.