Statistique de Copan Italia

164Dispositifs total

89UDI-DI de base

0Non destinés au marché UE

2Certificats

2Valides

0Expirant < 6 mois

3Pays

Santé des certificats de Copan Italia

Aucun dispositif enregistré pour ce fabricant.

Dispositifs placés dans 3 pays

Mise à jour EUDAMED : le 1 avr. 2025

IT-MF-000022535

Actif

Nom: Ministero della salute - Direzione generale dei dispositivi medici e del servizio farmaceutico
SRN: IT-CA-070
Téléphone: +39 06 5994 3199/ +39 06 5994 3207
Email: segr.dgfdm@sanita.it

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