AVITA Medical Americas, LLC

AVITA Medical Americas, LLC specializes in devices and kits for autologous skin cell grafting. These include processing systems like the RECELL GO Processing Device (RPD) and single-use cartridges (e.g., RECELL GO Processing Cartridge), as well as handheld devices and procedure packs (e.g., RECELL GO mini, RECELL®, and RECELL GO Procedure Pack A). The products are designed to harvest, prepare, and apply a patient’s own skin cells for therapeutic applications.

AVITA Medical Americas, LLC is based in the United States. While the company’s location influences its regulatory framework (e.g., FDA oversight for U.S. markets), individual devices must undergo their own authorization processes. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) system, indicating compliance with U.S. regulatory requirements for tracking and identification.

AVITA Medical Americas, LLC’s devices are listed in eudamed (the EU’s medical device registry) and the FDA’s UDI system (for U.S. tracking). These registries ensure transparency in device identification, compliance, and traceability. Listing in eudamed confirms the devices meet EU regulatory standards (e.g., MDR/AMDRA), while FDA UDI listings support post-market surveillance and recall coordination in the U.S.

AVITA’s devices fall into Class IIa, IIb, and III classifications under EU and U.S. regulations. Class III (highest risk) includes devices requiring rigorous pre-market approval, while Class IIa/IIb may involve simplified procedures like Notified Body assessments or 510(k) clearances. The classification determines the authorization pathway, with Class III devices requiring the most stringent evidence of safety and efficacy.