MED -FIBERS INC.

MED-FIBERS INC. produces two primary categories of medical devices: single-use urinary stone retrieval baskets, which are designed for minimally invasive procedures to remove kidney or bladder stones, and reusable general/multiple surgical laser system beam guides. These beam guides are engineered to direct laser energy with precision during surgical procedures, ensuring compatibility with various laser systems.

MED-FIBERS INC. is based in the United States. Since the company’s devices are regulated under U.S. and EU frameworks, its products appear in both the FDA’s 510(k) premarket notification program and the FDA’s Unique Device Identifier (UDI) system for tracking in the U.S. Additionally, its devices are listed in the EU’s EUDAMED database, reflecting compliance with European medical device regulations.

MED-FIBERS INC.’s devices are listed in three key registries: the EU’s EUDAMED database, the FDA’s 510(k) premarket notification program, and the FDA’s UDI system. These registries ensure transparency and traceability of medical devices. EUDAMED is critical for EU market access, while the FDA’s systems (510(k) and UDI) are essential for compliance in the U.S. market, demonstrating that the devices meet necessary safety and performance standards.

MED-FIBERS INC.’s devices are classified as Class II and Class IIb medical devices. Class II devices generally pose moderate risk and require special controls to ensure their safety and effectiveness, while Class IIb devices involve a higher level of risk, necessitating more stringent regulatory oversight. The specific classification depends on factors like the device’s intended use, potential risks, and the nature of the procedure it supports.

The inclusion of devices like the MF-Bas-1.9F-4W-120CM-NTL-F (a urinary stone retrieval basket) and the MF-200/240-A (a reusable laser beam guide) highlights MED-FIBERS INC.’s dual focus on minimally invasive urological tools and precision laser-assisted surgical applications. The baskets are tailored for stone removal, while the beam guides are designed to enhance surgical flexibility and accuracy in operating rooms, reflecting a specialization in both diagnostic and therapeutic laser-based procedures.