CE declaration of conformity

 
Declaration of Conformity Optical Frames

 

The company: LOOK VISION Registered office address: 7 rue de la Briqueterie, 95330 DOMONT, FRANCE (imported by LOOK VISION SRN: FR-MF-000040160)

 

This EU Declaration of Conformity is issued under the sole responsibility of LOOK VISION.

 

Declares that the product families described in this declaration are Risk Class I medical devices

(as defined in Rule 1 of Chapter III of Annex VIII of European Regulation 2017/745)

and are intended to be fitted with ophthalmic lenses for the purpose of correcting vision defects.

 

PRODUCT FAMILIES: Basic UDI-DI

 

Full-rim plastic frames 3664123OPCDT

 

Full-rim metal frames 3664123OMCDJ

 

Full-rim combination frames 3664123OXCEK

 

Half-rim plastic frames 3664123OPNEH

 

Half-rim metal frames 3664123OMNE8

 

Half-rim combination frames 3664123OXNF9

 

Rimless plastic frames 3664123OPPEM

 

Rimless metal frames 3664123OMPEC

 

Rimless combination frames 3664123OXPFD

 

See references

 

These products comply with the requirements of the MDR (EU) 2017/745 that apply to them and are compliant with the requirements of Safety and performance standards in accordance with EN ISO 12870:2016

 

Domont, June 29, 2022

 

LOOK VISION
M. YANG
Gérant

 

 

 

 

 



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Declaration of conformity for optical frames


The LOOK VISION company, based at 7 rue de la Briqueterie – 95330 DOMONT – France
EUDAMED Single registration Number LOOK VISION SRN: FR-MF-000040160


certifies that the optical frames without prescription lenses below (Class 1 medical device):

See references

 

are compliant with the requirements for Regulation (EU) 2017/745 according to the
EN ISO 12870 standard: 2016.

 

Domont, le 29/06/2022

 

LOOK VISION
M. YANG
Manager

 

 

 

 

 

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Declaration of conformity for sunglasses

 LOOK VISION, located at 7 rue de la Briqueterie – 95330 DOMONT – France (imported by LOOK VISION SRN: FR-MF-000040160)

certifies that the following solar radiation protective eyewear:

 

- complies with the provisions of Directive 89/686/EEC, as amended, until April 19, 2019

 

- complies with the provisions of EU Regulation 2016/425, effective from April 20, 2019, and with the harmonized standard EN ISO 12312-1:2013/A1:2015 "Personal protective equipment for the eye: Sunglasses and protective filters against solar radiation for general use," relating to Category I PPE.

 

- Given the current state of knowledge and technological developments, the product complies with the general safety requirements of the Directive. 2001/95/EC.

 

See references

 

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

 

Domont, 06/29/2022

 

LOOK VISION
M. YANG
Manager