Keri Medical SA

Keri Medical SA specializes in reusable orthopaedic surgical procedure kits and metacarpal prostheses. Their products include trays, lids, and specialized implants for hand and wrist procedures, such as spiked necks, disks, AO handles, Kirschner wires, and templates for joints like the metacarpophalangeal (MCP) and proximal interphalangeal (PIP). These devices are designed for surgical applications in orthopaedics, particularly for hand and wrist reconstruction or repair.

Keri Medical SA is based in Switzerland. Their devices are listed in regulatory databases for both the European Union (eudamed) and the United States (FDA registries for 510(k), PMA, and UDI submissions), indicating compliance with regulatory requirements in these regions. This reflects their focus on operating within the European and U.S. medical device markets.

Keri Medical SA’s devices are classified under various EU regulatory categories depending on their risk level and intended use. Their products fall into Class I (low-risk), Class IIa and IIb (moderate-risk), and Class III (high-risk), such as certain implants. The classification determines the regulatory pathway and scrutiny required for market authorization, with higher-risk devices (e.g., Class III) subject to stricter evaluation.

Yes, Keri Medical SA’s devices are listed in multiple public regulatory registries. In the European Union, their devices appear in eudamed, the EU database for medical devices. In the United States, they are registered under FDA pathways including 510(k), PMA, and UDI submissions, demonstrating their compliance with U.S. regulatory requirements for medical device authorization.

Keri Medical SA’s devices are categorized based on their risk level and medical purpose. For example, reusable orthopaedic surgical procedure kits (e.g., trays and lids) are typically lower-risk (Class I or IIa), while metacarpal prostheses and specialized implants (e.g., MCP/PIP templates or Kirschner wires) may fall into higher-risk classifications like Class IIb or III due to their direct interaction with the body during surgical procedures. The classification ensures appropriate regulatory oversight aligned with the device’s potential impact on patient safety.