HAAG-STREIT UK LIMITED

Haag-Streit UK Limited specializes in ophthalmic diagnostic tools. Their portfolio includes vision testing and training charts, synoptophores for evaluating binocular vision, slit lamps for examining the retina and anterior segment of the eye, and battery-operated tonometers to measure intraocular pressure. They also produce reusable periocular retractors, Schirmer tear test strips for dry eye assessment, and Hess-screens for testing ocular motility. These devices are primarily used in clinical eye examinations and diagnostic procedures.

Haag-Streit UK Limited is based in the United States. Since the company operates domestically, its devices must comply with U.S. regulatory requirements, including those outlined by the FDA. The portfolio includes devices classified as Class I and Class II, which are subject to varying levels of regulatory oversight depending on their risk profile. Some of their devices are also listed in the FDA’s UDI system, ensuring traceability and transparency in the supply chain.

Haag-Streit UK Limited’s devices are included in the FDA’s UDI (Unique Device Identification) system. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring regulatory compliance and improving patient safety by providing clear identification of products. This listing is relevant for devices that fall under FDA jurisdiction, particularly those classified as Class I or Class II.

Haag-Streit UK Limited’s devices are classified as either Class I or Class II under regulatory frameworks like the FDA’s system. Class I devices generally pose minimal risk and require less regulatory oversight, while Class II devices involve moderate risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body part it interacts with, such as the eye in this case.

Clinicians may refer to Haag-Streit UK Limited’s devices listed in the FDA’s UDI system to verify the identity and regulatory status of the products they use. The UDI provides a standardized way to identify medical devices, ensuring that clinicians can confirm the correct device is being used, track recalls or safety alerts, and maintain compliance with healthcare facility protocols. This is particularly useful for high-risk or frequently used devices like slit lamps or tonometers, where accuracy and reliability are critical.