aemiworld.com

AEMI WORLD.com

Bugenhagenstr.8 10551 Berlin Germany. 49 (30) 8472 8064. 49 (30) 8472 8065. Welcome to AEMI WORLD.com. European Authorized Representative for:. Medical Devices (MDD),. In Vitro Diagnostic Devices (IVDD). If your company does not have a physical location within the EU, European law for medical devices dictates that you must appoint a European Authorised Representative located in Europe to act as your liaison with the national Competent Authorities.

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Bugenhagenstr.8 10551 Berlin Germany. 49 (30) 8472 8064. 49 (30) 8472 8065. Welcome to AEMI WORLD.com. European Authorized Representative for:. Medical Devices (MDD),. In Vitro Diagnostic Devices (IVDD). If your company does not have a physical location within the EU, European law for medical devices dictates that you must appoint a European Authorised Representative located in Europe to act as your liaison with the national Competent Authorities.

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AEMI WORLD.com | aemiworld.com Reviews

https://aemiworld.com

Bugenhagenstr.8 10551 Berlin Germany. 49 (30) 8472 8064. 49 (30) 8472 8065. Welcome to AEMI WORLD.com. European Authorized Representative for:. Medical Devices (MDD),. In Vitro Diagnostic Devices (IVDD). If your company does not have a physical location within the EU, European law for medical devices dictates that you must appoint a European Authorised Representative located in Europe to act as your liaison with the national Competent Authorities.

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aemiworld.com

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AEMI WORLD.com

http://www.aemiworld.com/NR.html

MEDICAL DEVICE NATIONAL REGISTRATION. What is National Registration? In paragraph 1 it says, ‘Any manufacturer who, under his own name, places devices on the market in accordance with the procedures referred to in Article 11 (5) and (6) and any other natural or legal person engaged in the activities referred to in Article 12 shall inform the competent authorities of the Member State in which he has his registered address of business and the description of the devices concerned.

2

AEMI WORLD.com

http://www.aemiworld.com//COFS.html

CERTIFICATE OF FREE SALE. MEDIACAL DEVICE CERTIFICATE OF FREE SALE. The CE mark is an indication to show conformity to all obligations for medical devices as required by the Medical Devices Directives. With the CE mark in place your products can be legally marketed in Europe. In order to obtain a Free Sales Certificate / Certificate of Marketability for MDD and IVD devices the following information are needed:. 8226; Product names and/or model/part numbers.

3

AEMI WORLD.com

http://www.aemiworld.com//aboutUs.html

AEMI WORLD ABOUT US. The registration of medical devices confronts the manufacturers with significant challenges. National and international regulatory requirements are getting more tightened and breaking down into more detailed categories of devices. In case of Medical Device industry, Non-European Medical Device manufacturers, who wish to place their products into European market, must designate an Authorized Representative established in the European Community to fulfill one aspect of the requ...

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AEMI WORLD.com

http://www.aemiworld.com/index.html

Bugenhagenstr.8 10551 Berlin Germany. 49 (30) 8472 8064. 49 (30) 8472 8065. Welcome to AEMI WORLD.com. European Authorized Representative for:. Medical Devices (MDD),. In Vitro Diagnostic Devices (IVDD). If your company does not have a physical location within the EU, European law for medical devices dictates that you must appoint a European Authorised Representative located in Europe to act as your liaison with the national Competent Authorities.

5

AEMI WORLD.com

http://www.aemiworld.com/aboutUs.html

AEMI WORLD ABOUT US. The registration of medical devices confronts the manufacturers with significant challenges. National and international regulatory requirements are getting more tightened and breaking down into more detailed categories of devices. In case of Medical Device industry, Non-European Medical Device manufacturers, who wish to place their products into European market, must designate an Authorized Representative established in the European Community to fulfill one aspect of the requ...

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Bugenhagenstr.8 10551 Berlin Germany. 49 (30) 8472 8064. 49 (30) 8472 8065. Welcome to AEMI WORLD.com. European Authorized Representative for:. Medical Devices (MDD),. In Vitro Diagnostic Devices (IVDD). If your company does not have a physical location within the EU, European law for medical devices dictates that you must appoint a European Authorised Representative located in Europe to act as your liaison with the national Competent Authorities.

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