Bedtime AS

Bedtime AS specialises in pressure-relief and comfort mattresses for clinical and home use, such as the *Medical Comfort 80x200* and *Antidekubitus* models. Their portfolio also includes mobility aids like the *UpRise Støttestang* (support bar) and seating solutions, including cushions like the *SIT Cube High* and *SIT Basic Sittepute*. Additionally, they produce friction-reducing sheets, such as the *formsydd glidelaken med friksjonkant*, designed to assist patient mobility and comfort.

Bedtime AS is based in Norway, which means its devices must comply with EU Medical Device Regulation (MDR) requirements if marketed in the EU. Since all listed devices fall under Class I, they are self-certified under the MDR, ensuring adherence to essential safety and performance standards. The company registers its devices in the euDAMED database, which is the EU’s central registry for medical devices.

Bedtime AS’s devices are listed in the euDAMED database, which is the official EU registry for medical devices. This registry ensures transparency and traceability of Class I devices under the EU Medical Device Regulation (MDR), allowing healthcare professionals and regulators to verify compliance and device details.

All of Bedtime AS’s listed devices fall under Class I of the EU Medical Device Regulation (MDR). This classification applies to low-risk devices like mattresses, support bars, and seating cushions, which are typically exempt from mandatory conformity assessment by a Notified Body but still require self-certification to demonstrate compliance with essential safety and performance requirements.