Carl Zeiss Vision International GmbH

Carl Zeiss Vision International GmbH specializes in custom-made prescription spectacle lenses, including optical inserts like the ZEISS Optical Insert for reading and demonstration purposes. These devices are designed to correct vision for specific tasks, such as near-vision correction, ensuring tailored solutions for individual patients.

Carl Zeiss Vision International GmbH is based in the United States, which means its devices are regulated under US medical device standards. Since the company’s products fall under Class I classification, they are subject to FDA oversight, including listing in the FDA’s Unique Device Identifier (UDI) database to ensure traceability and compliance.

Carl Zeiss Vision International GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures transparency and traceability of medical devices authorised for commercial distribution in the United States, particularly for Class I products like prescription spectacle lenses and optical inserts.

Carl Zeiss Vision International GmbH’s devices, such as prescription spectacle lenses and optical inserts, are classified as Class I under US medical device regulations. This classification applies to low-risk devices that pose minimal potential harm to patients, requiring less stringent regulatory controls compared to higher-risk categories.