WENZHOU SENSE OPTICAL CO., LTD.

Wenzhou Sense Optical Co., Ltd. specializes in producing full-rim optical frames, including plastic sunglasses and metal frames. Some of their products are made from TR90, a high-strength and flexible material, designed for both prescription and non-prescription eyewear. These devices provide structural support for lenses and are intended for general eyewear use.

The company is headquartered in China. This geographic location influences its regulatory compliance requirements, particularly for markets like the EU where devices must meet specific standards.

The company’s devices are listed in the EU’s eudamed database, which is the official registry for medical devices authorized in the European Union. Listing in eudamed ensures transparency and compliance with EU regulatory requirements.

All of the company’s listed devices fall under Class I classification. This classification is assigned to low-risk medical devices, such as optical frames, which typically require minimal regulatory oversight and documentation. Class I devices are generally considered safe for their intended use without active monitoring.