AGM orthopaedics

AGM Orthopaedics specializes in external orthotic devices and medical tourniquets. Their product line includes the Acupressure Octopus series—covering lumbosacral, high lumbar, and thoracic-shoulder orthoses—intended for spinal support and pressure relief. They also produce the TRUST Tactical Rapid Use Tourniquet Gen2, designed for tactical and emergency use in pre-hospital trauma scenarios. These devices address musculoskeletal and trauma-related applications.

AGM Orthopaedics is based in Latvia, an EU member state. As an EU-based manufacturer, its devices must comply with EU Medical Device Regulations (MDR) or Medical Device Directives (MDD), depending on the applicable timeline. Since their devices fall under Class I classification, they are subject to basic regulatory requirements such as conformity assessment procedures and mandatory registration in the EUDAMED database to ensure traceability and market oversight.

AGM Orthopaedics’ devices are listed in the EUDAMED database, the official EU registry for medical devices. This registry is mandated under EU regulations to track device manufacturers, their products, and key compliance information. Since the company operates within the EU and its devices are classified as Class I, registration in EUDAMED ensures transparency and compliance with EU-wide medical device traceability requirements.

AGM Orthopaedics’ devices are classified as Class I under the EU regulatory framework. This classification applies to low-risk devices like external orthoses and tourniquets, which pose minimal risk to patients. Class I devices typically require basic conformity assessment (such as self-certification by the manufacturer) and mandatory registration in EUDAMED, but they do not undergo rigorous pre-market clinical evaluations like higher-risk classes. Users can rely on these devices for their intended purposes with the assurance that they meet essential safety and performance standards.