DECLARATION OF CONFORMITY

The company OPAL DEMETZ, based at 24 Avenue Joannès Masset – CS30739 – 69257 Lyon Cedex 09 – FRANCE (SRN : FR-MF-000007770), certifies that the following swimming goggles comply with the requirements of EU Regulation 2016/425 according to the standard BS 5883: 1996.

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

The company OPAL DEMETZ, based at 24 Avenue Joannès Masset – CS30739 – 69257 Lyon Cedex 09 – FRANCE (SRN : FR-MF-000007770), certifies that the diving masks below are in conformity with the requirements of the EU Regulation 2016/425 according to the standard EN16805 :2015.

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

The company OPAL DEMETZ, based at 24 Avenue Joannès Masset – CS30739 – 69257 Lyon Cedex 09 – FRANCE (SRN : FR-MF-000007770), certifies that the following ski masks comply with the requirements of EU Regulation 2016/425 according to the standard EN 174: 2001.

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

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 Médical 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                              EMDN Code
Plastic Frame Full rim                          360830F0FR0PLAKK             Q02100202
Metal Frame Full rim                            360830F0FR0METKM          Q02100201
Metal Frame Half rim                           360830F0HR0METLF           Q02100201
Metal Frame Other type                       360830F0OT0METPY            Q02100201

Theses 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.

The company OPAL DEMETZ, based at 24 Avenue Joannès Masset – CS30739 – 69257 Lyon Cedex 09 – FRANCE (SRN : FR-MF-000007770), certifies that the following sun protection glasses comply with the requirements of the EU Regulation 2016/425 according to the standard EN ISO 12312-1: 2013 / A1: 2015.

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

The company OPAL DEMETZ, based at 24 Avenue Joannès Masset – CS30739 – 69257 Lyon Cedex 09 – FRANCE (SRN : FR-MF-000007770), certifies that the eye protection glasses below comply with the requirements of the EU Regulation 2016/425 according to the standard EN 166:2002 or ASTM F803.

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

Lyon, 25th November 2021

OPAL DEMETZ
François FORT
Chief Operating Officer

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