WENZHOU INNOVISION OPTICAL CO., LTD

Wenzhou Innovision Optical Co., Ltd specializes in single-vision reading glasses for near-vision correction and optical frames designed for use with prescription or non-prescription lenses. These devices are primarily intended to assist with tasks like reading and correcting age-related presbyopia, which is the gradual loss of the eye’s ability to focus on close objects.

The company is headquartered in China, as indicated in its regulatory documentation. This location is relevant for understanding its manufacturing and compliance framework, particularly when assessing regulatory pathways for its devices.

The company’s devices are listed in the eudamed database, which is the EU’s central registry for medical devices under the EU Medical Device Regulation (MDR). Listing in eudamed confirms compliance with MDR requirements, ensuring traceability and transparency for authorized devices within the European market.

All devices manufactured by Wenzhou Innovision Optical Co., Ltd fall under Class I classification. This classification is assigned based on risk assessment criteria, where Class I devices are considered low-risk and typically require minimal regulatory scrutiny, such as conformity assessment procedures like self-certification or notified body involvement.