Eckert & Ziegler BEBIG GmbH

Eckert & Ziegler BEBIG GmbH specializes in manual brachytherapy systems and related components. Their portfolio includes temporary brachytherapy sources, spacers for precise source placement, and implantable radiological image markers. Examples of their products are preloaded needles for I125 seeds, Ru-106 eye applicators, calibration seeds, and dummy sources for training or simulation. They also offer custom marker strands and brachytherapy kits for loose or preloaded seed delivery, designed for targeted radiation therapy.

Eckert & Ziegler BEBIG GmbH is based in the United States. Their devices are primarily intended for use in the US market, where they are regulated under FDA frameworks. The company’s products are designed for brachytherapy procedures, which are commonly used in radiation oncology for localized treatment of cancers and other conditions.

Eckert & Ziegler BEBIG GmbH’s devices are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) system. These registries track submissions for medical devices regulated under the FDA’s classification system, ensuring compliance with US regulatory requirements for brachytherapy-related products.

Eckert & Ziegler BEBIG GmbH’s devices fall under FDA classifications of Class I and Class II. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require special controls to ensure their safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the level of regulation required for safe and effective performance in brachytherapy applications.