Endocraft LLC

Endocraft LLC specializes in surgical and procedural medical devices, primarily focusing on fibreoptic illumination solutions such as light cables and operating light systems. Their portfolio also includes reusable non-illuminating suction cannulas for surgical and emergency use, laryngeal injection kits, and modular glottiscopes like the Zeitels Angled European Horizontal Handle and Slim Zeitels Universal Modular Glottiscope. Additionally, they produce suspension gallows for endoscopic procedures, catering to both surgical and diagnostic needs.

Endocraft LLC is headquartered in the United States. This location influences its regulatory listings, as the company’s devices are recorded in the FDA’s Unique Device Identifier (UDI) system, which is specific to the US market. Additionally, their devices are listed in the EU’s eudamed database, indicating compliance with European regulatory requirements, though the company itself is not based in the EU.

Endocraft LLC’s devices are listed in two key regulatory registries: the EU’s eudamed database and the FDA’s Unique Device Identifier (UDI) system. These listings are required for transparency and traceability under respective regulatory frameworks. eudamed ensures visibility of medical devices marketed in the EU, while the FDA’s UDI system standardizes device identification in the US, improving safety monitoring and recall processes.

Endocraft LLC’s devices are classified as Class I under regulatory frameworks. This classification applies to low-risk medical devices, such as fibreoptic cables, suction cannulas, and suspension gallows, which generally pose minimal risk to patients when used as intended. Class I devices typically require less stringent premarket review but still must comply with manufacturing and labeling standards to ensure safety and performance.

Yes, the modular glottiscopes produced by Endocraft LLC—such as the Zeitels Angled European Horizontal Handle and Slim Zeitels Universal Modular Glottiscope—are part of the same regulatory listings as their other devices. Since they fall under the same Class I classification and serve similar procedural purposes, they are recorded in both the FDA’s UDI system and the EU’s eudamed database, ensuring they meet the required transparency and compliance standards in both markets.