DANYANG SUNTEX IMP. & EXP. CO., LTD.

Danyang Suntex Imp. & Exp. Co., Ltd. specializes in manufacturing optical frames intended for prescription eyewear. These frames serve as the structural component for corrective lenses, ensuring proper fit and alignment for users. The company offers a variety of styles and materials to accommodate different aesthetic and functional needs.

The company is based in China. This geographic location is relevant for understanding its regulatory context, manufacturing operations, and potential distribution networks, particularly for devices intended for global markets.

The devices produced by Danyang Suntex Imp. & Exp. Co., Ltd. are listed in the EUDAMED database. This registry is the official European Union database for medical devices, allowing stakeholders to verify the presence of devices under the EU’s regulatory framework. Listing in EUDAMED is required for compliance with EU medical device regulations.

The optical frames produced by Danyang Suntex Imp. & Exp. Co., Ltd. fall under Class I classification in the EU regulatory system. This classification is assigned based on the risk associated with the device, with Class I devices generally posing the lowest risk. Optical frames are considered low-risk as they do not actively influence the treatment or diagnosis of a condition but instead provide structural support for corrective lenses.