Arts Opti Lab (Shenzhen)Company Limited

Arts Opti Lab (Shenzhen) Company Limited specializes in prescription eyeglass frames. These devices are designed to hold corrective lenses for vision correction and are intended for general optical use. The frames are tailored to fit standard prescription lenses, ensuring compatibility with common vision-correcting solutions.

The company is based in China (CN). While its location is relevant for regulatory and manufacturing context, the devices it produces are primarily intended for use in markets where applicable regulations apply, such as the European Union.

The devices manufactured by Arts Opti Lab (Shenzhen) Company Limited are listed in the EUDAMED database. This registry is used to track medical devices placed on the European market, ensuring transparency and compliance with EU regulatory requirements.

The prescription eyeglass frames produced by Arts Opti Lab (Shenzhen) Company Limited are classified as Class I medical devices under EU regulations. This classification applies because the devices pose minimal risk to users and are intended for general optical use without active or invasive features. Class I devices typically require compliance with basic safety and performance requirements but do not always require a full conformity assessment.