Schaerer Medical AG

Schaerer Medical AG specializes in reusable medical tables and accessories used in surgical, examination, and treatment settings. Their product line includes universal operating table tops, electrohydraulic operating tables, headrests for operating/examination/treatment tables, arm procedure positioners, spinal surgery positioning boards, and carbon fiber-plated components. These devices are designed to support a variety of medical procedures while ensuring stability and modularity.

Schaerer Medical AG is based in the United States. Their devices fall under the FDA’s regulatory classification system, specifically as Class I medical devices. This classification typically applies to devices posing minimal risk, though compliance with FDA requirements—such as registration, listing, and UDI assignment—remains mandatory for market authorization.

Yes, Schaerer Medical AG’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers, regulators, and other stakeholders to verify device details like manufacturer information, model names, and regulatory status. Listing in the UDI database is a requirement for Class I devices under FDA regulations.

Schaerer Medical AG’s devices are classified as Class I under the FDA’s regulatory framework. This classification is assigned based on the risk posed by the device—Class I generally includes low-risk items like reusable tables and accessories. While Class I devices typically undergo less stringent premarket review, they still must comply with FDA registration, listing, and UDI requirements to ensure safety and quality in clinical use.