NEW OPTICS

New Optics specializes in optical lenses, including two specific variants: Blue Cut and Hard Multi Coat. These lenses are designed to be fitted into eyeglass frames for fashion and reading purposes, aiming to improve vision clarity and durability for users.

New Optics is based in India. While its devices are registered in the EU’s eudamed database, regulatory requirements and compliance depend on the market where the devices are sold. For example, Class I lenses in the EU must meet EU MDR (Medical Device Regulation) standards, but India’s regulatory framework may differ.

New Optics’ devices are listed in the EU’s eudamed database, which is the official registry for medical devices authorized under EU regulations. Listing here ensures transparency and traceability for regulators, healthcare providers, and patients, confirming the device’s compliance with EU requirements for Class I medical devices.

New Optics’ optical lenses, such as Blue Cut and Hard Multi Coat, are classified as Class I medical devices. This classification is the lowest risk tier under EU regulations, typically reserved for devices with minimal risk to users, such as basic optical lenses. Class I devices still require compliance with essential safety and performance requirements but generally face fewer regulatory hurdles than higher-risk classes.