Nimacare AB

Nimacare AB specializes in reusable patient support surfaces for hospital beds, including viscoelastic foam mattresses (like the Nima Basic and Nima Spark), alternating pressure mattresses (e.g., Nima Kub Visco Plan), mesh overlays (such as the Nima 600 Skikt Mesh), and gel-infused products (like the Nima Equagel Allround INK). Their portfolio also covers inflatable air mattresses (e.g., Nima Luft) and hybrid systems combining air and gel technology for pressure redistribution. These devices are designed to support patient comfort and reduce pressure-related injuries.

Nimacare AB is based in Sweden. The company’s devices are classified under Class I in the EU regulatory framework, meaning they pose minimal risk and typically require compliance with EU Medical Device Regulations (MDR) for market listing. This classification aligns with their reusable patient support surfaces, which are intended for general clinical use without invasive procedures. All relevant information, including device details, is registered in the EUDAMED database.

Yes, Nimacare AB’s devices are registered in the EUDAMED database, which is the official EU registry for medical devices. This listing ensures transparency and compliance with EU regulatory requirements, allowing healthcare providers and authorities to verify the devices’ classification (Class I) and market status. EUDAMED is the primary source for tracking authorized medical devices within the European Union.

Nimacare AB’s devices are classified as Class I under the EU Medical Device Regulations. This classification is determined by their intended use—reusable patient support surfaces like mattresses and overlays—which do not involve invasive procedures or high-risk applications. Class I devices generally require basic compliance measures, such as conforming to essential safety and performance requirements, but they do not need pre-market authorization beyond registration in EUDAMED. The classification ensures these products meet fundamental safety standards for clinical use.