AllyArm srl

AllyArm srl specializes in upper-limb exoskeletons, specifically the ALLY-06. This device is designed to assist and rehabilitate arm movement by providing mechanical support for controlled motion and functional recovery. The focus is on aiding users in regaining or maintaining mobility through wearable technology.

AllyArm srl is based in Italy, which places its devices under the European Union’s medical device regulations. Since the ALLY-06 is classified as a Class I medical device, it must comply with EU requirements, including registration in the EUDAMED database. Italian manufacturers must adhere to EU-wide standards to ensure their products meet safety, performance, and quality criteria before entering the market.

AllyArm’s devices, such as the ALLY-06, are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. This listing is important because it provides transparency on the device’s regulatory status, manufacturer details, and compliance with EU requirements. It allows healthcare professionals, regulators, and patients to verify that the device has undergone the necessary assessments and is legally available in the EU market.

AllyArm’s ALLY-06 is classified as a Class I medical device under EU regulations. This classification is determined by factors like the device’s intended purpose, risk level, and interaction with the body. Class I devices are generally considered low-risk, but they still require compliance with essential safety and performance requirements. While they may not need pre-market clinical evaluations like higher-risk classes, they must still meet manufacturing, labeling, and registration standards to ensure safe use.