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CE Mark Certification Service

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We have carved a niche amongst the most dominant names in this domain, involved in providing CE Mark Certification

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Eurotech Assessment And Certification Services Private Limited

West Saidapet, Chennai, Tamil Nadu
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Call +91-8048859535
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69% Response Rate
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Product Specification

Mode of Report Hard Copy
Location Preferences All Over India
Feature Executed by professionals

Product Description

We have carved a niche amongst the most dominant names in this domain, involved in providing CE Mark Certification Service.

Description:
  • Implement QMS as per annex II & V of MDD (not required for class I non sterile non measuring devices ).
  • Appoint an European authorized representative (required by non EU manufacturers only).
  • Identify the directive applicable to the medical device(MDD 93/42/EEC, IVD 98/79/EC, AIMD 90/385/EEC).
  • Classify the medical device as per Annex IX of MDD 93/42/EEC & 2007/47/EC.
  • Classify General & product specific standards as applicable to the medical device.
  • Prepare a technical dossier of product detailing manufacturing process, devices description, test reports, risk analysis, Instruction for Use, labeling, applicable standards etc.
  • Submit the technical dossier & QMS documents to notified body for approval.
  • Audits on site of QMS and technical files by notified body.
  • Prepare a declaration of conformity (DoC)(it is a declaration by manufacturer stating that the device is an compliance with the applicable directive ).
  • Affix CE mark on the medical device.
  • Translate IFUs & labels to the local language of the country to which you want to export.
  • Start distribution of CE affixed medical device in Europe.

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CE Mark Certification Service

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About the Company

Year of Establishment2010
Legal Status of FirmPrivate Limited Company
Nature of BusinessWholesale Trader
Number of EmployeesUpto 10 People
Annual TurnoverRs. 5 - 10 Crore
IndiaMART Member SinceJul 2011

We “Eurotech Assessment And Certification Services Pvt. Ltd.” came into being in the year of 2007 by the panel of experts. We are a prominent wholesaler of high quality products comprises of Testing Equipment, Testing Machine, Laboratory Chamber and many more. We are presenting these products in various packaging options to cater the vigorous demands of our patrons in effective manner. Our prestigious customers can obtain products from us at most reasonable prices within the stipulated period of time. Headquartered at Saidapet, Chennai, Tamil Nadu, we are working this realm as a Private Limited Company. In addition to this, we are backed by a vast and strong sharing network that aids us to enhance our product reach. Also, we are experts in providing CE Marking Certification Service, Electrical Testing Service, ISO Certification Service and many more.

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