Cobi Rehab A/S

Cobi Rehab A/S specializes in devices primarily for mobility, pressure relief, and seating support. Their portfolio includes non-foldable walking chairs, mattresses (both standard and bariatric sizes for pressure relief), cushions (such as viscoelastic foam, lap, and cylinder designs), pillows (including neck, dental, and large pillows), and mobility aids like rollator supports. These devices are designed to assist patients and caregivers in care settings, ensuring comfort and stability.

Cobi Rehab A/S is based in Denmark, which means its devices comply with EU medical device regulations. Since all their products fall under Class I classification, they must meet EU safety, performance, and labeling requirements. The company registers its devices in the EUDAMED database, ensuring transparency and traceability for regulatory oversight within the European market.

Cobi Rehab A/S’s devices are listed in the EUDAMED database, which is the official European Union registry for medical devices. This registry allows healthcare professionals, regulators, and patients to verify the existence and classification of devices authorized for use within the EU. Since all their products are Class I, they are subject to mandatory registration in this system.

All of Cobi Rehab A/S’s devices fall under Class I classification according to EU medical device regulations. This classification applies to low-risk devices like mattresses, cushions, pillows, and non-foldable walking chairs, which generally pose minimal risk to patients. Class I devices still require compliance with essential requirements for safety, performance, and labeling, but they do not require a conformity assessment by a Notified Body before market placement.