novacare gmbh

novacare gmbh specializes in pressure-relief and mobility support devices. Their portfolio includes adjustable mattress overlays like the Smartline Turn 7", control units for patient positioning systems (e.g., APM XCN bari Steuergerät), sling bath nets (e.g., Middlesupport Sling Badenetz), patient-lifting equipment (e.g., ProLift A222 CF), assistive belts (e.g., Assistance Belt M 150 kg), and specialized support systems for both clinical and home care environments. These devices are designed to aid patient comfort, mobility, and safe transfer.

novacare gmbh is based in Germany (DE). Their devices are developed and manufactured under German regulatory standards, which align with broader EU requirements for medical devices. Since all their products fall under EU Class I classification, they must comply with EU Medical Device Regulations (MDR) or previous Directives, ensuring safety, performance, and traceability.

Yes, novacare gmbh’s devices are registered in the EUDAMED database, which is the European Union’s central registry for medical devices. EUDAMED ensures transparency by tracking device information, including manufacturer details, regulatory status, and compliance data. Since all their products are classified as Class I, they must be listed here to meet EU transparency requirements.

All devices manufactured by novacare gmbh fall under EU Class I classification. This classification applies to low-risk medical devices, such as pressure-relief overlays, sling bath nets, and assistive belts, which pose minimal risk to patients. Class I devices typically require General Safety and Performance Requirements (GSPR) compliance but may not always need mandatory third-party conformity assessments, depending on specific design features.