Copan Italia S.P.A.

• Ministero della salute - Direzione generale dei dispositivi medici e del servizio farmaceutico
  ItalieContacter l’autorité →

Dispositifs placés dans 3 pays

• Italie257
• Allemagne15
• Belgique2

6 contacts identifiés

• MM
  MANGANIELLO Maddalena

  PCVRR
  Voir le profil →
• SC
  SABELLI Cristiano

  PCVRR
  Voir le profil →
• ZE
  ZANELLA Elisabetta

  PCVRR
  Voir le profil →
• ZANELLA Elisabetta
  - the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date - the post-market surveillance obligations are complied with in accordance with Article 10(10) [Article 10(9) of the IVDR] - the reporting obligations referred to in Articles 87 to 91 [Article 82 and 86 of the IVDR] are fulfilled
  Masqué
• SABELLI Cristiano
  - the post-market surveillance obligations are complied with in accordance with Article 10(10) [Article 10(9) of the IVDR] - in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV [Section 4.1 of Annex XIV of the IVDR] is issued
  Masqué
• MANGANIELLO Maddalena
  -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
  Masqué

• Copan Italia — IT-MF-000022535
• Copan Italia — IT-PR-000033865
• TÜV SÜD Product Service GmbH — 3 certificats — Copan Italia
• MANGANIELLO Maddalena — Copan Italia
• SABELLI Cristiano — Copan Italia
• ZANELLA Elisabetta — Copan Italia