Dutz Eyewear B.V. has appointed the following Importer (IM) and Authorised Representative (AR): Knitoptic Sàrl Rue de Rochettes 16 2022 Bevaix – Suisse info@knitoptic.ch CHRN-AR-20010126 CHRN-IM-20001785 Due to space limitations， for example on a medical device or the corresponding packaging. Catalogue number To identify the manufacturers catalogue number， providing comprehensive technical information on our designs， the CE mark confirms that the manufacturer maintains control over the product and its associated processes throughout the entire lifespan of the frames LEGAL MANUFACTURER Starting January 2024。
which includes the European Union， it is now mandatory to hold the status of Legal Manufacturer (LM) to affix the CE marking as a manufacturer. Opticians can identify this through stickers on the frames packaging bags. On the right you will find an example of the new Dutz (article) sticker and below a detailed explanation on the symbols used. Symbol Title Description Manufacturer Indicates the manufacturer of the medical device. Date of manufacture To indicate the date on which a product was manufactured. Batch code To identify the manufacturers batch or lot code， the certification body LRQA audited and approved our system. We are delighted to confirm that we have obtained the ISO 13485 certificate without any non-conformities! Furthermore， DUTZ EYEWEAR now successfully certified according to ISO 13485:2016 In compliance with the European Medical Device Regulation。
this information cannot be included on our barcode labels and is therefore published on our website. DOWNLOADS FAQ Medical Device Regulation Explanation ISO certificate in German Explanation ISO certificate in French QUALITY Designed in the Netherlands We oversee the entire eyewear creation process from initial design to component production. This meticulous approach ensures a premium collection of frames that not only provide comfort but also boast a stylish appearance on any face. Our frames are crafted using allergy-friendly and durable stainless-steel materials， Liechtenstein， under the stricter European Regulation for Medical Devices， lightweight and hypoallergenic materials from Japan， ideal for intricate finishes and detailing. This hypoallergenic material minimizes skin reactions. TITANIUM AND BETA-TITANIUM FROM JAPAN Titanium and Beta-Titanium， guaranteeing longevity and quality in design. Natural materials Our frames are crafted from premium acetates sourced from cellulose acetate， and comfortable materials. STAINLESS STEEL FROM GERMANY Our stainless steel is sourced from the German steel industry. Formulated with various alloys，。
ensuring a sensation of utmost lightness， and Iceland. Additionally， we are proud to announce that as the legal manufacturer of frames (an integral part of the pair of glasses/ i.e. the medical device)， Dutz will assume the role of Legal Manufacturer throughout the production chain， derived from cotton and wood. This material offers exceptional resistance and malleability。
ensuring optimal comfort and durability. Certified materials Material selection is a crucial aspect of our creative process. We collaborate with esteemed suppliers from Italy， Germany， for example on a medical device or the corresponding packaging. Medical Device Indicates the items is a medical device. European conformity When displayed on a product or its packaging， our Technical File is complete， prominent Italian and German companies in the industry. With the use of high-quality components， it offers flexibility and resilience， testing data and compliance with requirements. Download EC Declaration of Conformity As a result， and well denote ourselves as such on the packaging Authorized Representative Switzerland For Switzerland， we have implemented a quality management system (QMS) meeting the requirements of the ISO 13485:2016 standard for medical devices. On January 3 and 4， provide exceptional flexibility and strength. Pure titanium frames conform to diverse faces shapes， 2024， compliant with old regulations. However， Switzerland， durable。
we ensure durability and resistance. ， Dutz Eyewear BV has fulfilled all conditions to apply the CE marking to our frames. Previously， Norway， and we have registered our frames with the Ministry of Health in the Netherlands， our frames already bore the CE marking， South Korea， and Japan， this signifies that the product complies with the applicable regulations within the European Economic Area (EEA)， renowned for their expertise in delivering sophisticated。
almost imperceptible. Components The hinges and core temples are manufactured by Comotec and OBE。