Declarations of conformity of medical and protective gloves documents. We, plantronics bv, declare under our sole responsibility that the following products are in conformity with 201430eu, 201165eu and carries the ce marking. The european union eu requires a declaration of conformity doc to the eu legislation, called directives, for products that are placed on the market within the eu. Plum 360 infusion pump 22973519665 plum 360 infusion pump single declaration of conformity 828042162193 page 2 of 6 this is a declaration made under the sole responsibility of icu medical in accordance with the. A declaration of conformity is a document stating that a product, usually electronic, meets the standards to which it must legally adhere, such as safety regulations.
A declaration of conformity is a document stating that a product, usually electronic, meets the standards to which it must legally adhere, such as safety. Compliance is applicable from the date listed below. It is a legal document that is mandatory for products that fall within the scope of. By drawing up and signing the eu declaration of conformity, the manufacturer assumes responsibility for the compliance of the product. Reach declaration of conformity alicat scientific, inc. Regulatory compliance eu declaration of conformity. The conformity assessment procedure used for this declaration is annex iii of red 201453eu and the product will bear the cemarking ce accordingly. Rblhg5hpnd to which this declaration refers conforms with the relevant harmonized standards under. Radio equipment directive 201453eu red rohs2 directive 201165eu.
The eu declaration of conformity which is the most common term used in ce marking is a document confirming that the product is placed in the market in accordance with the relevant product legislation. Covered by this declaration is in conformity with the following directives, standards or other. This declaration of conformity is issued under the sole responsibility of the manufacturer. 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.
In order to market your electrical electronic products in europe you need to compose a. Eu declaration of conformity document number month. Abb frequency converters acs550, ach550, acs350 and acs800. Declaration of conformity 3m espe dental products division declares that devices abrasives listed on the attached device schedule conform to the relevant provisions of the ec council directive 9342. And are produced under a quality scheme at least in conformity with iso 9001 or cenelec permanent documents. The following accessories and components, including software, allow the object of the declaration described above to operate as intended and in conformity with this eu declaration of conformity. Ec declaration of conformity according to 200642ec, annex 2a we abb ab jokab safety varlabergsvagen 11 se434 39 kungsbacka sweden declare that the safety components of abb ab make with type designations and safety functions as listed below, is in conformity with the directives 200642ec machinery 201430eu emc 201165eu rohs. Scorpius 171 22 lr hoofddorp the netherlands for and on behalf of plantronics bv. Producing a declaration is one of the integral tasks involved in ce marking a product or machine. As a senior official of the manufacturer, having responsibility for the regulatory compliance of the medical device with the requirements of the canadian medical devices regulations and this declaration of conformity, i hereby declare that the information i have provided in support of the safety and effectiveness of the medical device to be. Product code 1 1122 2 1920 3 1120 4 1121 5 1123 6 1220 7 1222 8 1221 9 1223 10 20 11 21 12 22 23 product name product revision. Its just a document that you sign to congratulate yourself of the great job you have done and to swear that you have respected all the laws.
The publication and the copy of the contents, even a part, in. The ce marking on a dell product indicates conformity to the provisions of applicable european union eu directives. By signing the doc you take full responsibility for your products compliance with the applicable eu law. Eu declaration of conformity philips to which this declaration relates is in conformity with the following harmonized standards. The declaration of conformity should be written on an official union language. Declaration of conformity below is an example of a european declaration of conformity and an example form for a declaration of conformity. Ped directive 201468eu, emc directive 201430 eu, atex directive 201434eu. The eu declaration of conformity doc is the manufacturers declaration that the product complies with those directives. Tussendiepen 4, 9206 ad drachten, the netherlands address adresse declare under our responsibility that the products. Declaration of conformity according to mdr and pper. In the united states, the mark of the federal communications commission fcc is considered to be a declaration.
Declaration of conformity type ico3is solenoids, are hereby declared in conformity with the following directives. This letter applies to lla alloys and fluxes except lead containing solders and cadmium containing products. But if you are making this doc to another member state, youll need to translate it to the official language of this country. Below is an example of a european declaration of conformity and an example form for a declaration of conformity. The object of the declaration described above is in conformity with directive 201165eu and all amendments of the european parliament and of the council of 8 june 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment. The atex directive 201434eu equipment intended for use in potentially explosive atmospheres directive. Cable cubby 100 power module not included, cable cubby 500 ac module not included, cable cubby 500 ccb ac module not included, cable cubby 700 ac module not included. All supporting documentation is retained at the premises of the manufacturer. Equipment and protection systems for agreed using in explosive areas. Ec dated 14 june 1993 and is in accordance with en46001.
In the case your products needs a declaration of conformity for many legislation, you can list all the compliant. Ec declaration of conformity this declaration of conformity is issued under the sole responsibility of the manufacturer. Manufacturers declaration of conformity technical file number. Burozuil enkel ins02501619 burozuil enkel ins02501679 burozuil enkel ins02501719 burozuil enkel ins02501779 burozuil dubbel ins02502619 burozuil dubbel ins02502679 burozuil dubbel ins02502719 burozuil dubbel ins02502779 buiszuil enkel spaninrichting ins02511719. Example of a declaration of conformity ce marking assistant. This declaration is issued under the sole responsibility of. Declaration of conformity for the following equipment. The declaration of conformity loses its validity if the product is misused or modified without authorization from bisol proizvodnja,d. The declaration of conformity will never be issued by a notified body or a test house. This declaration of conformity is issued under the sole responsibility of the manufacturer who declares that the above described radio equipment is in conformity with the following relevant union harmonisation legislations. The doc is where you make the required statement of conformity of your product with all applicable ec directives.
The object of declaration is in conformity with directive 201165eu on the restriction of the use of certain hazardous substances in electrical and electronic equipment and commission delegated directive eu 2015863 amending annex il to directive 201165eu of the european parliament. The word declaration of conformity is written 38 times on the eu mdr 2017745. We hereby declare under our sole responsibility that the following apparatus. This is, if i may say, a pillar on the medical device regulation process. The declaration of conformity is a document that needs to be signed by the manufacturer, wherein heshe declares that a certain product sold within the european union complies with the essential requirements of the relevant european product safety legislation. English pdf danish pdf dutch pdf finnish pdf french pdf german. Eu declaration of conformity to which this declaration relates is in conformity with the following harmonized standards. For you as a manufacturer, this document is your way of confirming that the product you are putting on the market is safe and manufactured to acceptable standards. The declaration of conformity certifies the compliance of a product. Conformity has been demonstrated with reference to the following documentation. I know when you read, the requirements, this looks easy. The object of the declaration described above is in conformity with the following relevant union harmonization directives andor legislations. Eu declaration of conformity we hereby declare under our sole responsibility that the following products scroll indoor condensing units.
Signed for and on behalf of evoluent place and date of issue. Introduction suppliers declaration of conformity sdoc is an fcc equipment authorization procedure that requires the party responsible for compliance to ensure that the equipment complies with the appropriate technical. Declaration of conformity work equipment and machinery. Eu declaration of conformity emerson to which this declaration relates, is in conformity with the provisions of the following european assumption of conformity is based on the application of the harmonized standards and, when applicable or required, a european community notified body certification, as shown in the attached schedule. English pdf danish pdf dutch pdf finnish pdf french pdf german pdf italian pdf norwegian pdf polish pdf spanish pdf swedish pdf eu declaration of conformity. For most new products the declaration of conformity must accompany the product through the supply chain to the end user. The eu declaration of conformity is the document in which the manufacturer states that the product satisfies the essential requirements of the applicable legislation. Limited room 1205, 12f, harbour crystal centre, 100 granville road, tsimshatsui east, kowloon, hong kong item no sr10012 recoil starter set the object of the declaration described above is in conformity with. The declaration of conformity needs to be issued and signed by the person that places the product on the european market, mostly the manufacturer or the importer of a product. Declaration of conformity we, tektelic communications inc.
Declaration of conformity declaration of conformity doc reference information file number. Rohs directive 201165eu low voltage directive 201435eu. Ec declaration of conformity we, the undersigned, manufacturer. Ec declaration of conformity in the sense of the guide line 201434eu. To incorporate these partly completed machinery into a machine the declaration of incorporation according to the machinery directive has to be observed. The undersigned hereby declares, on behalf of the xyz corp. Legal compliance and disclosures eu declaration of conformity.
Technical documentation and eu declaration of conformity. This article gives some guidance on creating the document and avoiding simple mistakes. Conformity to the essential requirements of the legislations have been demonstrated by using the following standards. Ndr 120x x12,24,48 is herewith confirmed to comply with the requirements set out in the council directive, the following standards were applied. You can find the eu doc for your lenovo product here. Place and date of issue name, surname, and signature of authorized person prebold, 1. And are produced under a quality scheme at least in conformity with iso 9001 or cenelec permanent documents only for medical devices produced under a quality scheme at least in conformity with en485. Declarations of conformity guidance and common errors. Ped directive 201468eu, emc directive 201430eu, atex directive 201434eu. The undersigned hereby declares that the above reference products to which this declaration relates is in conformity with the provisions of. We herewith declare that the above mentioned products are in conformity with the council directive 9342eec for medical devices including the mdd amendment 200747ec, directive 201165eu of the european parliament and of the council of 8 june 2011 on the restriction of the. An exception to this is for electrical equipment within scope of the low voltage directive 200695ec where key information about the product must be supplied, and although a declaration of conformity must be drawn up by the. Abb automation technologies ab, lv motors s721 70 vasteras, sweden hereby declares that the vsd drive combinations. Declaration of conformity we, sia mikrotikls pernavas 46 riga, lv1009 latvia declare that the product model.
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