Cochlear Bone Anchored Solutions AB

SRN

SE-MF-000012413

Rôle

Fabricant

Pays

Suède

Nom de l'organisation

Cochlear Bone Anchored Solutions AB

Numéro TVA UE

SE556561711401

Date d'enregistrement

30 août 2021

Email

emea-submission@cochlear.com

Adresse

14, KONSTRUKTIONSVÄGEN SE-435 33 MÖLNLYCKE SUÈDE

Nom

Swedish Medical Products Agency

SRN

SE-CA-030

Téléphone

+46 18 17 46 00

Email

registrator@lakemedelsverket.se

• DAHLBERG Jenny
  a) The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released c) The post-market surveillance obligations are complied with in accordance with Article 10(10) d) The reporting obligations referred to in Articles 87 to 91 are fulfilled (Reference: MDR 2017/745 Article 15(3))
  Masqué
• LOID Annika
  b) The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date e) In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued (Reference: MDR 2017/745 Article 15(3))
  Masqué

Aucun certificat enregistré pour ce fabricant.

Aucun document enregistré pour cette entreprise pour le moment.