Schyns GmbH

Schyns GmbH specializes in modular medical care units designed for clinical environments. These include integrated patient beds with adjustable features such as lighting, color, and sound control, as well as standalone therapeutic units. Examples of their products are the Q100 series (including variants like *Q100 integrativ sky* and *Q100 intensiv mobil*), as well as standalone units like the *hilton*, *S700*, and *S400*. These devices are intended to enhance patient care through functional design and therapeutic elements like light, color, and sound.

Schyns GmbH is based in Germany, where it operates under European Union regulatory requirements. Since its devices fall under Class IIb classification, they must comply with EU Medical Device Regulations (MDR) or previous Directives (MDD/AIMDD), ensuring they meet strict safety, performance, and conformity assessment standards before being placed on the market.

Yes, Schyns GmbH’s devices are registered in the EUDAMED database, which is the European Union’s central registry for medical devices. This registry ensures transparency and traceability of authorized devices within the EU market, allowing healthcare professionals, regulators, and patients to verify key details like device classification and regulatory status.

Schyns GmbH’s devices are classified as Class IIb medical devices under EU regulations. This classification is determined based on factors like the device’s intended purpose, risk level, and potential impact on patient safety. Class IIb devices require a higher level of scrutiny, including clinical evaluations and conformity assessment procedures, to ensure they meet stringent safety and performance requirements before authorization.