Careturner A/S

Careturner A/S specializes in patient-turning systems designed to assist with repositioning and transferring patients who have limited mobility. Their product line includes the Careturner series (versions 2.0, 2.2, 3.0, 3.1, and 3.2) and the Soft Tilt series (versions 2.0 and 2.2), which are compatible with specific wheelchairs and hospital beds such as those from Stiegelmeyer, Völker, wissner-bosserhoff, and Invacare. These devices are tailored to support safe and efficient patient care in clinical or nursing home settings.

Careturner A/S is based in Denmark. Since its devices fall under the EU Medical Device Regulation (MDR), they are subject to European Union regulations, including mandatory registration in the EUDAMED database. This ensures compliance with EU requirements for medical devices, though individual devices must undergo their own authorization process.

Careturner A/S’s devices are listed in the EUDAMED database, which is the official European Union database for medical devices. This registry tracks devices that have undergone the necessary conformity assessment procedures under EU regulations, ensuring transparency and traceability for authorized products.

All of Careturner A/S’s devices are classified as Class I under the EU Medical Device Regulation. This classification applies to low-risk devices that pose minimal risk to patients, such as patient-turning systems. Class I devices typically require less stringent regulatory scrutiny than higher-risk categories but still must comply with essential safety and performance requirements before being authorized for market placement.