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Add: ZhangJiaDi Village, WangQingTuo Town, WuQing District, TianJin, China

General manager: Miss.Carry

Tel: +86-022-29512420
Mob: +8613302033255
E-mail: carry@tianjinlinkang.com

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Electric wheelchair exports to the EU countries need to apply for certification?
Mar 01, 2018

With the rapid development of smart technology, many products are extending to the intelligent direction. The electric wheelchair is one of the more mature products in which technologies are used. Most of the member states of the EU are developed countries, which have serious problems of aging and a developed economy. Therefore, they have sufficient market space. Many Chinese manufacturers will consider the EU market when they choose to explore overseas markets. However, if they want to enter the EU market, they also need to apply for CE certification of electric wheelchairs.

Electric wheelchair CE certification process:

1, the application for certification - the technical information provided by the enterprise, the certification body based on the information to determine the applicable directives and standards

2, sign the contract - the enterprise and the certification body to sign the CE mark certification contract

3, product pre-test - the certification body will send samples to the relevant laboratory tests authorized

4, the final product inspection - Enterprises to adjust the product, fill in the relevant formalities, the laboratory gives the final test report

5, corporate rectification - enterprises under the final inspection report rectification

 

6, Technical Review - laboratory technical review of the product

7, Certificate Issuance - product evaluation is qualified, issued by the EU authorized agencies to issue certificates to the product

Electric wheelchair CE certification information list:

a. Name, trade name, address of the manufacturer (Authorized Representative of the EU (EU Authorized Agent) AR).

b. Product model number.

c. product manual.

d. Safety Design Documents (Key Block Diagram, a design that reflects creepage distances, gaps, insulation layers, and thickness).

e. Product technical conditions (or enterprise standards).

f. Product electrical schematic.

g. product road map.

h. List of critical components or raw materials.

i. Testing Report.

j. Relevant certificate issued by the EU authorized certification body NB (for modes other than model A).

k. Certificate of registration of the product within the European Union (for certain products such as Class I medical devices, general IVD IVD medical devices).


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    Add: ZhangJiaDi Village, WangQingTuo Town, WuQing District, TianJin, China

    General manager: Miss.Carry

    Tel: +86-022-29512420
    Mob: +8613302033255
    E-mail: carry@tianjinlinkang.com

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