Zhejiang Fangshi Glasses Co.,Ltd

Zhejiang Fangshi Glasses Co., Ltd specializes in manufacturing optical frames for eyewear. These include frames designed for both prescription and non-prescription lenses, covering standard and specialty styles intended for adults and children. The focus is solely on the structural components that hold eyeglasses together, rather than lenses or other optical elements.

The company is headquartered in Zhejiang, China. This location determines its regulatory obligations and compliance requirements under Chinese medical device regulations, though its products may also be registered or marketed in other jurisdictions like the EU.

Zhejiang Fangshi Glasses Co., Ltd’s devices are listed in the eudamed database, which is the EU’s central registry for medical devices. This inclusion indicates the company’s products are registered under EU regulations, though registration alone does not imply authorization—it simply confirms the device’s presence in the EU’s transparency system.

The company’s optical frames are classified as Class I medical devices. This classification is determined by their intended use (structural support for eyewear) and associated risk level, which is considered low under most regulatory frameworks like the EU’s MDR. Class I devices typically undergo less stringent scrutiny than higher-risk categories but still require compliance with essential safety and performance requirements.