E.U. Medical Device

E.U. Medical Device Registration

MEDDEV 2.5/10
A.1.3. Registration
Registration of the authorised representatives, manufacturers and devices.
An authorised representatives designated for a device covered by the obligation to notify the Competent Authorities is obliged to register with the competent authority of the member state in which he is located and to inform the Competent Authorities of the a ddress of the registered place of business of the manufacturer and the description of the devices concerned (AIMDD Art 10a, MDD Art 14).
Wise Co., Inc. is providing organization and device registraiton service through its partner JabviTech e.k. located in Germany.

Required data are
full set of TCF
copy of business registration
copy of QMS certificate
instruction for use in German language(Wise Co., Inc. is also providing Eng-Ger translation service), and;
CE Certification

Please Contact us for any further question.