Statistique de HAE SA

29Dispositifs total

10UDI-DI de base

0Non destinés au marché UE

0Certificats

0Valides

0Expirant < 6 mois

2Pays

Santé des certificats de HAE SA

Aucun certificat enregistré pour ce fabricant.

Aucun dispositif enregistré pour ce fabricant.

Dispositifs placés dans 2 pays

Mise à jour EUDAMED : le 12 déc. 2025

CH-MF-000034549

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

RYAN Julie
The technical documentation and the EU declaration of conformity in respect of the Devices are drawn up and kept up-to date; In the case of investigational devices (if any), the statement referred to in Section 4.1 of Chapter II of Annex XV of the MDR is issued; and In the case of devices for performance studies intended to be used in the context of interventional clinical performance studies, the statement referred to on section 4.1 of Chapter I of Annex XIV of the IVDR is issued.
Masqué
KILLION Jim
The conformity of the Devices is appropriately checked, in accordance with the quality management system under which the Devices are manufactured, before each Device is released; The post-market surveillance obligations related to the Devices are complied with in accordance with the Regulations; and The vigilance reporting obligations (as referred to in Articles 87 to 91 of the MDR and Articles 82 to 86 of the IVDR) are fulfilled in respect of the Devices
Masqué