Statistique de Alifax

3Dispositifs total

2UDI-DI de base

0Non destinés au marché UE

0Certificats

0Valides

0Expirant < 6 mois

1Pays

Santé des certificats de Alifax

Aucun certificat enregistré pour ce fabricant.

Affichage de 1–3 sur 3 dispositifs.

Dénomination commerciale	Numéro de référence/catalogue	Code d'UDI-DI	Quantité	Statut
SI 1001.900-L	`SI 1001.900-L`	`08056040149287`	60	Sur le marché
SI 1701.0102/L	`SI 1701.0102/L`	`08056040149249`	1	Sur le marché
SI 1701.0102/5L	`SI 1701.0102/5L`	`08056040149201`	1	Sur le marché

Dispositifs placés dans 1 pays

Mise à jour EUDAMED : le 13 sept. 2024

IT-MF-000030029

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

FALCONE Francesco
ensuring items set forth in Article 15, par. 3, letters a and d of Regulation (EU) 2017/746, notably that: (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; (d) the reporting obligations referred to in Articles 82 to 86 are fulfilled.
Masqué
MARINI Eleonora
ensuring items set forth in Article 15, par. 3, letters b, c and e of Regulation (EU) 2017/746, notably that: b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (c) the post-market surveillance obligations are complied with in accordance with Article 10(9); (e) in the case of devices for performance studies intended [...], the statement referred to in Section 4.1 of Annex XIV is issued.
Masqué