Eu medical device certification Caretechion GmbH
Caretechion GmbH, located in Dusseldorf, Germany, is a third-party service provider specializing in international standard testing, certification, inspection and consulting. As a partner and consultant, we guide medical device manufacturers to secure, comply with standards and obtain global market approvals for their products to successfully complete their entire product lifecycle. We accompany our customers to grow in the international market for a long time, from product concepts to successful international market recognition, we serve you with comprehensive and long-term professional knowledge. To help companies improve performance, increase visibility and promote sustainable development.
Our company has a number of EU authorizations in different product areas, opening the road to the international market for Chinese exporters. It has provided business consulting services in the EU to hundreds of Chinese medical device manufacturers. As your strong ODAI and regulatory partner to help your medical device products successfully enter the EU market. As the EU authorised representative of your medical device, it will act as your legal entity before the competent authorities of the EU, representing you, performing its duties in accordance with the Medical Device Directive and providing other services for your product to enter the EU market.
According to the official directive of the European Union, manufacturers of medical devices, in vitro diagnostic medical devices and cosmetics that are established outside the European Union must designate an EC Representative for themselves. If the manufacturer does not have a physical location in Europe and needs to appoint a European authorised representative, ODAI can perform specific duties on behalf of the manufacturer outside the EEA as required by the relevant directives and laws of the European Union for that manufacturer.
Attach CE mark
ISO quality system
Free sale certificate
European representatives
Professional team to help Chinese export enterprises to the international market
Our company has a group of senior, professional, dedicated, excellent technical engineers, in different product fields we have a number of EU authorization announcements, and many foreign local partners reached a strategic cooperation alliance.Our company has a group of senior, professional, dedicated, excellent technical engineers, in different product fields we have a number of EU authorization announcements, and many foreign local partners reached a strategic cooperation alliance.
With many years of accumulated experience, we provide "one-stop" services such as product testing, standard consulting, certification application, obtaining certification, and technical support for Chinese export enterprises.
According to the official directive of the European Union, manufacturers of medical devices, in vitro diagnostic medical devices and cosmetics established outside the European Union must designate an EC Representative for themselves. If the manufacturer does not have a physical location in Europe and needs to appoint a European authorised representative, ODAI can perform specific duties on behalf of the manufacturer outside the EEA as required by the relevant directives and laws of the European Union for that manufacturer.
Authoritative certification
Our company has long cooperated with EU notified bodies
There are a number of testing and certification bodies in the EU, each with a different directive and standard mandate to carry out the basic health and safety assessment required for the corresponding product before it is placed on the EU market. The company is managed in strict accordance with ISO quality standards. Has been recognized by many international certification bodies, including Germany TUV, EMCC, PTL, Hong Kong EMSD, Norway NEMKO and so on.
Rich in experience
Familiar with the technical inspection standards of various countries
With experienced professional and technical personnel, the company has a group of professional talents with more than 5 years of experience, skilled in various international certification operations, to provide you with professional one-stop certification services. Through our efforts, you can obtain a wide range of authoritative international certifications in a short time.
Full service
Meet the various needs of enterprises
Before entering the German market, Chinese companies need to have an understanding of the supply and demand of the products to be launched. The market research specialists at StateLab GmbH provide professional product research analysis, data processing and cooperation with the relevant industry practitioners in Germany to provide customers with reliable product market information.
