Bien-Air Surgery SA

SRN

CH-MF-000016376

Rôle

Fabricant

Pays

Suisse

Nom de l'organisation

Bien-Air Surgery SA

Numéro TVA UE

CHE-109.303.111

Registre du commerce

CH-670.3.002.607-1

Date d'enregistrement

10 nov. 2021

Adresse

2B, RUE DE L'OUEST 2340 LE NOIRMONT SUISSE

Email

surgery@bienair.com

Site web

https://surgery.bienair.com/

Nom

Agence Nationale de Sécurité du Médicament et des Produits de Santé

SRN

FR-CA-008

Téléphone

+ 33 (1) 5587 3000

Email

contact.eudamed@ansm.sante.fr

• CORMIER Clémentine
  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
• TSOLEKAS Dimitrios
  • Conformity of the Technical Documentation and EU Declaration of conformity • Compliance with Post-Market Surveillance (PMS) following Article 10(10) • Compliance with the Vigilance Reporting obligations (Article 87 to 91) Art. 87- Reporting of serious incidents and field safety corrective actions Art. 90- Analysis of vigilance data Art. 91- Implementing acts • For Investigational devices: Issuance of a signed statement (Annex XV Chapter II Section 4.1)
  Masqué
• RAZAFINTSEHENO Rivo
  • Compliance with the Vigilance Reporting obligations (Article 87 to 91) Art. 87- Reporting of serious incidents and field safety corrective actions Art. 88- Trend reporting Art. 89- Analysis of serious incidents and field safety corrective actions Art. 90- Analysis of vigilance data Art. 91- Implementing acts
  Masqué

Dispositifs placés dans 6 pays

• Autriche26
• France10
• Belgique1
• Espagne1
• Pologne1
• Portugal1

Affichage de 1–25 sur 40 dispositifs.