DECLARATION OF CONFORMITY OPTICAL FRAMES

The company : OPAL DEMETZ SAS
EUDAMED Single registration Number (SRN) : FR-MF-000003768
Address : 24 Avenue Joannès Masset – CS30739 – 69257 Lyon Cedex 09– France
International nomenclature : GMDN 32816

This declaration of conformity is issued under the sole responsibility of OPAL DEMETZ.

Opal DEMETZ declare that the product groups described in this declaration, can be defined as Class I Medical Devices (Rule 1, Chapter III, of de Annex VIII of EU regulation 2017/745) and are intended for use in connection with ophthalmic lenses for correcting vision problems.

Product Groups                    Basic UDI DI
Plastic Frame Full rim        360830F0FR0PLAKK
Metal Frame Full rim          360830F0FR0METKM
Metal Frame Half rim         360830F0HR0METLF
Metal Frame Other type     360830F0OT0METPY

These products complies with the applicable requirements of the Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices, and complies with European Standard EN ISO 12870 : 2016.

Lyon, 1st April 2022

OPAL DEMETZ
François FORT
CEO

DECLARATION OF CONFORMITY PERSONAL PROTECTIVE EQUIPMENT

We OPAL DEMETZ with registered office in 24 Avenue Joannès Masset – CS30739 – 69257 Lyon Cedex 09 – France (SRN : FR-MF-000003768), declare that the glasses designed to protect you from solar radiation hereafter:

Comply with the EU regulation 2016/425 according to the current reference standard EN ISO 12312-1: 2013 / A1 : 2015.

The above EU declaration of conformity is issued under the sole responsibility of the manufacturer.

Lyon, 25th November 2021

OPAL DEMETZ
François FORT
CEO

DECLARATION OF CONFORMITY FRAMES WITH ANTI-BLUE LIGHT TREATED LENSES

We OPAL DEMETZ with registered office in 24 Avenue Joannès Masset – CS30739 – 69257 Lyon Cedex 09– France, declare that the frames with anti-blue light treated lenses hereafter:

Comply with the requirements of EU Regulation 2016/425 according to the standard of EN 166: 2002.

OPAL DEMETZ
François FORT
CEO

DECLARATION OF CONFORMITY READING GLASSES

We OPAL DEMETZ with registered office in 24 Avenue Joannès Masset – CS30739 – 69257 Lyon Cedex 09– France, declare that the glasses made for reading hereafter:

Comply with the requirements of EN 14139.

OPAL DEMETZ
François FORT
CEO