GreenBone Ortho Spa

SRN

IT-MF-000033034

Rôle

Fabricant

Pays

Italie

Nom de l'organisation

GreenBone Ortho Spa

Numéro TVA UE

02493440396

EORI

IT024903440396

Registre du commerce

RA-206894

Date d'enregistrement

26 janv. 2023

Adresse

8, ALBERT EINSTEIN 48018 FAENZA ITALIE

Téléphone

+39 054646666

Email

info@greenbone.it

Site web

www.greenbone.it

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

• BONOMI Vanessa
  1) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; 2) the post-market surveillance obligations (PMS Plan, PSUR) are complied with in accordance with Article 10(10) 3) to ensure the vigilance reporting obligations referred to in Articles 87 to 91 are fulfilled
  Masqué
• CHA Andrea
  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
• SALVAGNO Susanna
  1) the technical documentation (CEP, CER, SSCP) is drawn up and kept up-to-date; 2) the post-market surveillance obligations (PMCF) are complied with in accordance with Article 10(10) 3) to ensure  in the case of devices for performance studies intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
  Masqué

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Dispositifs placés dans 1 pays

• Italie83