HERAEUS MEDICAL COMPONENTS LLC

Heraeus Medical Components LLC specializes in guidewires and related vascular devices. Their portfolio includes manual and single-use guidewires for peripheral and cardiac/peripheral vascular procedures, such as the Spring Coil Guidewire and Selectiva. They also produce specialized gastro-urological guidewires, peripheral vascular intervention infusion catheters (e.g., Poseidon), vascular microcatheters, and kits for extracting or repositioning vena cava filters. These devices are designed for interventional radiology, cardiology, and gastroenterology applications.

Heraeus Medical Components LLC is based in the United States. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites may vary.

Devices from Heraeus Medical Components LLC are listed in multiple regulatory databases, including the EU’s EUDAMED registry for European Union compliance tracking. In the U.S., their devices appear in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system, which catalogs medical devices for identification and traceability purposes.

Heraeus Medical Components LLC’s devices fall into various FDA classification categories depending on their risk level and intended use. Their portfolio includes Class I (low-risk) devices like some guidewires, Class II (moderate-risk) devices such as infusion catheters and microcatheters, Class IIa (a subset of Class II with specific regulatory controls), and Class III (high-risk) devices, which require premarket approval due to their critical role in patient safety or efficacy. Classification is determined by the FDA based on factors like procedure invasiveness and potential harm.