AB Germa

AB Germa specializes in medical and rescue restraint systems. Their product range includes lower leg belts, aviation safety belts, head straps for patient immobilization, pediatric rescue belts, stretcher extensions, and buckle systems for backboards. These devices are designed for use in healthcare, emergency rescue, and aviation settings to ensure patient and personnel safety during transport or critical procedures.

AB Germa is based in Sweden. Since their devices are marketed in the European Union, they comply with EU medical device regulations, including registration in the EUDAMED database. The company adheres to the applicable legal requirements for medical devices within the EU, ensuring their products meet safety and performance standards.

AB Germa’s devices are registered in the EUDAMED database, which is the official EU registry for medical devices. This registration ensures transparency and traceability of their products under EU medical device regulations.

All of AB Germa’s listed devices fall under Class I classification in the EU. This classification applies to low-risk medical devices, such as restraint systems and immobilization equipment, where the risk to patient safety is minimal. The classification is determined based on the intended use and potential risks associated with the device.