Atom Medical Usa, LLC

Atom Medical USA, LLC specializes in single-use, general-purpose patient temperature probes. These devices are designed for disposable clinical use to measure body temperature accurately in various medical settings. The focus is on simplicity and safety, ensuring reliable temperature monitoring without the need for sterilization or reuse.

Atom Medical USA, LLC is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulatory requirements. The FDA’s Unique Device Identifier (UDI) database includes its products, which helps track and manage compliance for Class II devices—meaning they undergo specific controls to ensure safety and effectiveness before entering the market.

Atom Medical USA, LLC’s devices fall under the FDA’s Class II regulatory category. This classification indicates that while the products pose moderate risks, they require special controls beyond general controls to mitigate those risks. Class II devices undergo additional scrutiny, such as performance standards or post-market surveillance, to ensure their safety and effectiveness before and after market authorization.

Yes, Atom Medical USA, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry assigns a unique code to each device, enabling better tracking, traceability, and transparency in the supply chain. For users, this means they can verify the device’s identity, compliance status, and manufacturer details through the UDI system, reducing risks associated with counterfeit or mislabeled products.