In accordance with the Medical Device Regulation, we provide the declarations of conformity for our models for download. Below you will find the declarations of conformity for our optical frames and sunglasses. Each category is available as a PDF document with an attached model list. Additionally, the sunglasses warnings are available as a separate PDF document for download.
Declaration of Conformity
Instructions for use and safety information
Spectacle frames are Class I medical devices in accordance with Regulation (EU) 2017/745 on medical devices. Sunglasses comply with Regulation (EU) 2016/425 on personal protective equipment as well as the EN ISO 12312-1 standard. Category 3 sunglasses are suitable for strong sunlight, for example at the beach or in the mountains. They are not suitable for direct viewing of the sun and must not be used for driving at dusk or at night.The adjustment of spectacle frames must be carried out by qualified professionals. This product is not intended to protect against mechanical risks.
In case of visible damage or skin reactions, use must be discontinued. For cleaning, the use of a soft microfiber cloth is recommended. If necessary, the glasses can be cleaned with water and a mild detergent. Aggressive chemicals must be avoided.Serious incidents in connection with a spectacle frame must be reported to the manufacturer and the competent authority.
Manufacturer: EINSTOFFEN GmbH, Engelgasse 12A, CH-9000 St. Gallen.EU Responsible Person: EINSTOFFEN Europe GmbH, Fritz-Arnold-Straße 12, DE-78467 Konstanz
