eu declaration of conformity check
If you are willing to give us more details, please fill in this survey. 519060 ZHUHAI 0756-6266298 jeffreyqiu@erp-asia.com The CE marking must be visible, legible and indelible. Some products are subject to several EU requirements at the same time. Thank you for your feedback. Declaration of conformity. Aeotec declares that the European edition of Z-Stick Gen5, Z-Stick Lite Gen5, ZW090-C, ZW092-C, conforms with the relevant European Union harmonisation legislation. Object of the declaration: Listed above. It is required for products manufactured anywhere in the world that are then marketed in the EU. As part of conformity assessment, the manufacturer or the authorised representative must draw up an declaration of conformity (DoC). If you wish to reduce or enlarge the CE marking on your product, you should respect the proportions of the two letters. Title: EU Declaration of Conformity - SUNNY ISLAND 4.4M / 6.0H / 8.0H (SI4.4M-13, SI6.0H-13, SI8.0H-13) Author: SMA Solar Technology AG Subject: Herstellererklärung Keywords: SI44M13, SI60H13, SI80H13, Konform-ce Created Date: 9/23/2019 1:27:23 PM It will only take you a couple of minutes. have made available for free a number of standards for medical devices and personal protective equipment: Many products require CE marking before they can be sold in the EU. It is a criminal offence to affix a CE mark to a product that is not compliant or offer it for sale. If you need to involve a notified body, the CE marking must be accompanied by the identification number of the notified body. If you are willing to give us more details, please fill in this, Licensing and selling intellectual property, Infringement of intellectual property rights, Taxes on parent companies and subsidiaries, Request a review of a public procurement procedure, E-commerce, distance and off-premises selling, Package travel and linked travel arrangements, Technical documentation and EU declaration of conformity, Classification, labelling and packaging of chemicals, conformity assessment for protective equipment, conformity assessment for 3D printing and 3D printed products to be used in a medical context, applicable legislation for leave-on hand cleaners and hand disinfectants (gel, solution), national contact points for medical devices, EN 149:2009 Respiratory protective devices – Filtering half masks to protect against particles - Requirements, testing, marking (commonly referred to as 'FFP masks'), EN 14683:2019 EN Medical face masks - Requirements and test method, EN 166:2001 Personal eye-protection – Specifications, EN 14126:2003 Protective clothing - Performance requirements and tests methods for protective clothing against infective agents, EN 14605:2009 Protective clothing against liquid chemicals - performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only, EN 13795-1:2019 Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns, EN 13795-2:2019 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods, EN 455-1:2000 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes (MDD), EN 455-2:2015 Medical gloves for single use - Part 2: Requirements and testing for physical properties (MMD), EN 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation (MDD), EN 455-4:2009 EN Medical gloves for single use - Part 4: Requirements and testing for shelf life determination (MDD), EN ISO 374-5:2017 Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risks, EN ISO 13688:2013 Protective clothing - General requirements, EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, EU regulation on product requirements and market surveillance, EU decision on a common framework for the marketing of products, Publications Office of the European Union, determine whether you can assess your product by yourself or if you have to involve a. declares that the Apex 300 is in compliance with directive RoHS 2.0 (2015/863/EU),EMC Directive (2014/30/EU), and LVD (2014/35/EU) issued by the Commission of the European Community. An EU declaration of conformity (DoC) is a mandatory document that you as a manufacturer or your authorised representative need to sign to declare that your products comply with the EU requirements. The EU declaration of conformity shall state that the requirements specified in this Regulation have been fulfilled in relation to the device that is covered. EU Declaration of Conformity . This includes estimating and documenting the possible risks when using your product. Presumption of conformity is based on the application of the harmonized standards, normative documents or other documents and, when applicable or required, a European Community The EU Declaration of Conformity for each model of Dash Cam can be downloaded from the below link. Object of the declaration: Listed above. If your product doesn't need to be verified by an independent body, then it is up to you to check that it complies with the technical requirements. You can download the CE marking image files from the DG GROW portal. national contact points for medical devices EU Declaration of Conformity Document number: 2021 / 9C1-3365628-EN-09 3/3 . We can supply you with the COC for: passenger vehicles (M1) I usually put 1 year. The EU Declaration of Conformity should continuously be updated. The Declaration of Conformity is issued at the end of the CE marking process, and it only applies to products falling within the scope of one or more of the CE directives. This declaration of conformity is issued under the sole responsibility of the manufacturer. It is proof of a product’s compliance with the European legislation on product safety. EU declaration of conformity. The EU Declaration of conformity must be issued prior to placing the product on the market. Michael P Hereby, SteelSeries ApS. EU Declaration of Conformity We, Decawave Ltd, Adelaide Chambers, Peter Street, Dublin D08 T6YA, Ireland do hereby declare under our sole responsibility that the following product: Product Name: DWM1000 Module Model Number: DWM1000 An EU declaration of conformity (DoC) is a mandatory document that you as a manufacturer or your authorised representative need to sign to declare that your products comply with the EU requirements. This means that you should include an expiry date on it. The manufacturer shall continuously update the EU declaration of conformity. : P0015745 Page 1 of 2 Manufacturer: Signify I.B.R.S./C.C.R.I. CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements. EU Declaration of Conformity (DOC) We Company name: Postal address: Postcode: City: Telephone number: E-Mail address: Energy Recovery Products(Zhuhai)Co.,Ltd No.8 Pingdong Road 2 Zhuhai,Guangdong China. Article 19 EU declaration of conformity 1. However, the market surveillance authorities may ask you to translate the technical documentation depending on the EU country where the product has been placed on the market. The conformity of the designated product(s) with the provisions of this European Directive is given by the compliance with the following European Standard(s) or other specifications. The EU declaration of conformity shall, as a minimum, contain the information set […] The DoC declares that a product is in compliance with all relevant European product safety requirements. declarations of conformity Our vehicles have systems that transmit and / or receive radio waves subject to Directive 1999/5/EC or 2014/53/EU. This analysis must be included in the technical documentation. A Declaration of Conformity (DoC) is an official certificate drawn up by the manufacturer or their authorised representative. Rival 700 Mice. EU Declaration of Conformity: Rival 700 Products. It is a highly official and legally binding document that should only be signed by a … What is a Declaration of Conformity? draft and sign an EU declaration of conformity Once your product bears the CE marking — if the competent national authority requests — you must provide them with all the information and supporting documentation concerning CE marking. EU Declaration of Conformity, also known as DOC is a document in which the manufacturer declares that the Medical Device/In-Vitro Diagnostic Device complies with the requirements of MDR/IVDR and all the Union legislation applicable to the device. Apex 300_CE DOC.pdf. The EU declaration of conformity shall state that the requirements specified in this Regulation have been fulfilled. You need this documentation in order to affix the CE marking to the product. The declaration of conformity is issued under the sole responsibility of the manufacturer. By drawing up and signing the EU Declaration of Conformity, the manufacturer assumes responsibility for the compliance of the product. Michael P Hereby, SteelSeries ApS. European standardisation bodies Thank you for your feedback. However, if you opt to use the services of a notified body, or if the EU specifications applicable to your product require the independent assessment by a notified body, then you must pay the notified body for the service they provide. As a manufacturer, you are responsible for identifying all the possible risks your product could pose and determine the applicable essential requirements. The technical documentation should include at least: As a manufacturer, you should be able to demonstrate where and how the various parts of the document are held and maintained. EU Declaration of Conformity: Apex 300 Products. The declaration of conformity is a document that needs to be signed by the manufacturer, wherein he/she declares that a certain product sold within the European Union complies with the essential requirements of the relevant European product safety legislation. Both procedures help ensure the smooth functioning of the internal market. If you are willing to give us more details, please fill in this, Licensing and selling intellectual property, Infringement of intellectual property rights, Taxes on parent companies and subsidiaries, Request a review of a public procurement procedure, E-commerce, distance and off-premises selling, Package travel and linked travel arrangements, Technical documentation and EU declaration of conformity, Classification, labelling and packaging of chemicals, conformity assessment for protective equipment, conformity assessment for 3D printing and 3D printed products to be used in a medical context, applicable legislation for leave-on hand cleaners and hand disinfectants (gel, solution), national contact points for medical devices, EN 149:2009 Respiratory protective devices – Filtering half masks to protect against particles - Requirements, testing, marking (commonly referred to as 'FFP masks'), EN 14683:2019 EN Medical face masks - Requirements and test method, EN 166:2001 Personal eye-protection – Specifications, EN 14126:2003 Protective clothing - Performance requirements and tests methods for protective clothing against infective agents, EN 14605:2009 Protective clothing against liquid chemicals - performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only, EN 13795-1:2019 Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns, EN 13795-2:2019 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods, EN 455-1:2000 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes (MDD), EN 455-2:2015 Medical gloves for single use - Part 2: Requirements and testing for physical properties (MMD), EN 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation (MDD), EN 455-4:2009 EN Medical gloves for single use - Part 4: Requirements and testing for shelf life determination (MDD), EN ISO 374-5:2017 Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risks, EN ISO 13688:2013 Protective clothing - General requirements, EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, The ‘Blue Guide’ on the implementation of EU products rules, Publications Office of the European Union, ensure the technical documentation is made available to the market surveillance authorities (should they request to see it), keep the technical documentation for 10 years, your name and address, or those of any authorised representatives, identification of the product, for example, the product's serial number, the name(s) and address(es) of the facilities involved in the design and manufacture of the product, a statement of relevant regulations to which the product complies, identification of technical standards with which compliance is claimed, your name and full business address or that of your authorised representative, the product's serial number, model or type identification, a statement, stating you take full responsibility, means of identification of product allowing traceability – this can include an image, the details of the notified body which carried out the, the relevant legislation with which the product complies, as well as any, supplementary information (if applicable). The manufacturer shall continuously update the EU declaration of conformity. Phone: (847) 600-2000 Web: www.Shure.com Certify and declare under our sole responsibility that the following apparatus: Model: … This declaration of conformity is issued under the sole responsibility of the manufacturer. Your Product Contact Point can inform you on national product legislation and help you access another national market in the EU. Get in touch with specialised assistance services, Get advice on EU rules that apply to your business / solve problems with a public authority. /Numéro 10461 5600 VB Eindhoven, The Netherlands Year in which CE Mark was first affixed : 201 8 This declaration of conformity is issued under the sole responsibility of the manufacturer. Thank you for your feedback. Or you should stipulate on a procedure like “Change management” when a change should trigger the update of the Declaration of Conformity. 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