DECLARATION OF CONFORMITY

OPAL, registered at 24 Avenue Joannès Masset – CS30739 – 69257 Lyon Cedex 09 – FRANCE (SRN: FR-MF-000007770), hereby certifies that the swimming goggles listed below comply with the requirements of Regulation (EU) 2016/425 in accordance with standard BS 5883:1996.

This declaration of conformity is issued under the sole responsibility of the manufacturer.

OPAL, registered at 24 Avenue Joannès Masset – CS30739 – 69257 Lyon Cedex 09 – FRANCE (SRN: FR-MF-000007770), hereby certifies that the diving masks listed below comply with the requirements of Regulation (EU) 2016/425 in accordance with standard EN 16805:2015.

This declaration of conformity is issued under the sole responsibility of the manufacturer.

OPAL, registered at 24 Avenue Joannès Masset – CS30739 – 69257 Lyon Cedex 09 – FRANCE (SRN: FR-MF-000007770), hereby certifies that the ski goggles listed below comply with the requirements of Regulation (EU) 2016/425 in accordance with standard EN 174:2001 or EN ISO 18527-1:2022.

This declaration of conformity is issued under the sole responsibility of the manufacturer.

OPAL SAS EUDAMED
Single Registration Number (SRN): FR-MF-000003768
Registered address: 24 Avenue Joannès Masset – CS30739 – 69257 Lyon Cedex 09- France
Global Medical Device Nomenclature: GMDN 32816

This EU Declaration of Conformity is issued under the sole responsibility of OPAL.
Hereby declares that the product categories listed in this declaration are medical devices of risk class I (within the meaning of Annex VIII, Chapter III, Rule 1 of Regulation (EU) 2017/745) and are intended to be fitted with ophthalmic lenses for the purpose of correcting sight defects.

Product categories: Basic ophthalmic lenses
Full-rim plastic frames 360830F0FR0PLAKK
Full-rim metal frames 360830F0FR0METKM
Half-rim metal frames 360830F0HR0METLF
Metal frames – other assembly 360830F0OT0METPY

These products meet the applicable requirements of Regulation (EU) 2017/745 on medical devices (MDR) and the safety and performance requirements of EN ISO 12870:2016.

OPAL, registered at 24 Avenue Joannès Masset – CS30739 – 69257 Lyon Cedex 09 – FRANCE (SRN: FR-MF-000007770), hereby certifies that the sunglasses listed below comply with the requirements of Regulation (EU) 2016/425 in accordance with standard EN ISO 12312-1:2013/A1:2015.

This declaration of conformity is issued under the sole responsibility of the manufacturer.

Lyon, 25 November 2021

OPAL
François Fort
Chairman and CEO