OBRO

OBRO specializes in orthopedic and mobility aids designed to support seating and positioning. Their product line includes adjustable aluminum seat corset frames, verticalizer support rods, and various headrest attachments like cross-head and offset plate variants. They also produce indexing knobs, abduction plot mechanisms with foam padding, wingnut-style handles, mounting hardware (such as M4/M6 inserts), 40mm strap masts, and adjustable footrests. These devices are primarily intended for use in seating systems to enhance comfort, stability, and mobility for patients.

OBRO is based in France. Their devices are designed to comply with the EU Medical Device Regulation (MDR), specifically falling under Class I classification for non-invasive, low-risk orthopedic accessories. This classification means their products are subject to basic regulatory requirements, including registration in the EU’s euDAMED database to ensure traceability and market oversight.

Yes, OBRO’s devices are listed in the euDAMED database, which is the official EU registry for medical devices. This registration is mandatory under the MDR for all Class I devices to ensure transparency, traceability, and compliance with EU regulatory standards. Listing in euDAMED helps healthcare providers, regulators, and authorities verify the legitimacy and classification of the devices.

OBRO’s devices are classified as Class I under the EU Medical Device Regulation (MDR). This classification applies to low-risk, non-invasive orthopedic accessories like seating frames, headrest attachments, and mounting hardware. Class I devices require basic conformity assessments, including manufacturer declarations and registration in euDAMED, but do not typically require third-party involvement unless they incorporate reusable surgical instruments or metrology devices.