Declaration of Conformity
EU DECLARATION OF CONFORMITY
DESCRIPTION OF PRODUCT:SUNGLASSES
BRAND NAME;LINDA FARROW, LINDA FARROW LINEAR, LINDA FARROW GALLERY, THE ATTICO;MATTHEW WILLIAMSON, DRIES VAN NOTEN, NO 21, Y PROJECT, ALEXANDER RICH, MARCELO BURLON, AREA NEW YORK, ERDEM, PHILIP LIM, JACQUEMUS, MAGDA BUTRYM, NUE STUDIO.
We declare that the products listed above comply with both the CE and UKCA marks and all the relevant EU directives in relation to Personal Protective Equipment (PPE)
These sunglasses comply with the safety requirements set out by - Regulation EU 2016/425 and subsequent amendments effective April 2019; - the requirements set forth in EN ISO 12312-1: 2013/Amendment:; 2015 Standard.
Regulation (EC) No 1907/2006 on the Registration Evaluation, Authorization and Restriction of Chemicals (REACH).
DESCRIPTION OF PRODUCT: OPTICAL FRAMES
BRAND NAMES: Linda Farrow, Linda Farrow Linear, Jacquemus.
Name and Address of Manufacturer:
Bally Sunglass & Optical Company Limited
1 Rosoman Place
London. EC1R 0JY
UK
This Declaration of Conformity is issued under the sole responsibility of the manufacturer.
We Bally Sunglass & Optical Co Ltd confirm the products described in this declaration conform to the relevant provisions of Medical Device Regulation (EU) 2017/745 and are placed on the market under this regulation.
This Declaration of Conformity also applies to placing the devices on the Swiss market in accordance with the Swiss Medical Device Ordinance (MedDO, SR 812.213).
European Authorized Representative:
MedEnvoy Global BV
Prinses Margrietplantsoen,
33 The Hague 2595 AM
Netherlands
+31 703262148
SRN: NL-AR-000024028
Basic UDI-DI - 5054275LFLOPTICAL6K
ITEMS:
Class 1, non-sterile, non-measuring function.
According to Annex VIII – MDR 2017/745 Chapter III 4.1 Rule 1 (non-invasive with no intention to channel any substance nor modify any chemical or biological composition of the body (or part of the body) nor come into contact with broken skin or membranes).
Intended Purpose:
To provide a supportive structure for corrective lenses for vision correction.
GMDN Code: 32816
EMDN Code: Q021002 – Spectacle Frames without lenses
Common Specifications: None applicable
RELEVANT DIRECTIVES:
EN ISO 12870: 2018 OPHTHALMIC OPTICS / SPECTACLE FRAMES
EN 16128: 2015
(EC) No. 1907/2006 – REACH ANNEX XVII AND ITS AMENDMENT
Signed for and on behalf of
Bally Sunglass & Optical Company Limited.
Simon Jablon
CEO